The Association Between Breastfeeding and Growth Among Infants with Moderately Low Birth Weight: A Prospective Cohort Study.

OBJECTIVE: To assess the association between breastfeeding competency, as determined by Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) and Preterm Infant Breastfeeding Behavior Scale (PIBBS) scores, and exclusive breastfeeding and growth among infants with low birth weight (LBW) in India, Malawi, and Tanzania. STUDY DESIGN: We conducted LATCH and PIBBS assessments among mother-infant dyads enrolled in the Low Birthweight Infant Feeding Exploration (LIFE) observational study of infants with moderately LBW (1500g-2499 g) in India, Malawi, and Tanzania. We analyzed feeding and growth patterns among this cohort. RESULTS: We observed 988 infants. We found no association between LATCH or PIBBS scores and rates of exclusive breastfeeding at 4 or 6 months. Higher week 1 LATCH and PIBBS scores were associated with increased likelihood of regaining birth weight by 2 weeks of age [LATCH: aRR 1.42 (95% CI 1.15, 1.76); PIBBS: aRR 1.15 (95% CI 1.07, 1.23); adjusted for maternal age, parity, education, residence, delivery mode, LBW type, number of offspring, and site]. Higher PIBBS scores at 1 week were associated with improved weight gain velocity (weight-for-age z-score change) at 1, 4, and 6 months [adjusted beta coefficient: 1 month 0.04 (95% CI 0.01, 0.06); 4 month 0.04 (95% CI 0.01, 0.06); and 6 month 0.04 (95% CI 0.00, 0.08)]. CONCLUSION: Although week 1 LATCH and PIBBS scores were not associated with rates of exclusive breastfeeding, higher scores were positively associated with growth metrics among infants with LBW, suggesting that these tools may be useful to identify dyads who would benefit from early lactation support.

RAPIDIRON Trial follow-up study - the RAPIDIRON-KIDS Study: protocol of a prospective observational follow-up study.

BACKGROUND: Anemia is a worldwide problem with iron deficiency being the most common cause. When anemia occurs in pregnancy, it increases the risk of adverse maternal, fetal, and postnatal outcomes. It induces preterm births and low birth weight (LBW) deliveries, long-term neurodevelopmental sequelae, and an increased risk of earlier onset of postnatal iron deficiency. Anemia rates are among the highest in South Asia, and India's National Family Health Survey (NFHS-5) for 2019-2021 indicated that over half of pregnant women, and more than 65% of children, in the country are classified as anemic (Sciences IIfP, National Family Health Survey-5, 2019-21, India Fact Sheet). In 2021, the parent RAPIDIRON Trial (Derman et al., Trials 22:649, 2021) was initiated in two states in India, with the goal of assessing whether a dose of intravenous (IV) iron given to anemic women during early pregnancy results in a greater proportion of participants with normal hemoglobin concentrations in the third trimester and a lower proportion of participants with LBW deliveries compared to oral iron. As a follow-up to the RAPIDIRON Trial, the RAPIDIRON-KIDS Study will follow the offspring of previously randomized mothers to assess, neurobehavioral, hematological, and health outcomes. METHODS: This prospective observational cohort study will follow a subset of participants previously randomized as part of the RAPIDIRON Trial and their newborns. Study visits occur at birth, 6 weeks, 4 months, 12 months, 24 months, and 36 months and include blood sample collection with both maternal and infant participants and specific neurobehavioral assessments conducted with the infants (depending on the study visit). The primary outcomes of interest are (1) infant iron status as indicated by both hemoglobin and ferritin (a) at birth and (b) at 4 months of age and (2) the developmental quotient (DQ) for the cognitive domain of the Bayley Scales of Infant Development Version IV (BSID-IV) at 24 months of age. DISCUSSION: This RAPIDIRON-KIDS Study builds upon its parent RAPIDIRON Trial by following a subset of the previously randomized participants and their offspring through the first 3 years of life to assess neurodevelopmental and neurobehavioral (infants, children), hematological, and health outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT05504863 , Registered on 17 August 2022. Clinical Trials Registry - India CTRI/2022/05/042933 . Registered on 31 May 2022.

Facilitators, barriers, and key influencers of breastfeeding among low birthweight infants: a qualitative study in India, Malawi, and Tanzania.

BACKGROUND: Low birthweight (LBW) infants are at increased risk of morbidity and mortality. Exclusive breastfeeding up to six months is recommended to help them thrive through infection prevention, growth improvements, and enhancements in neurodevelopment. However, limited data exist on the feeding experiences of LBW infants, their caregivers and key community influencers. The qualitative component of the Low Birthweight Infant Feeding Exploration (LIFE) study aimed to understand practices, facilitators, and barriers to optimal feeding options in the first six months for LBW infants in low-resource settings. METHODS: This study was conducted in four sites in India, Malawi, and Tanzania from July 2019 to August 2020. We conducted 37 focus group discussions with mothers and family members of LBW infants and community leaders and 142 in-depth interviews with healthcare providers, government officials, and supply chain and donor human milk (DHM) experts. Data were analyzed using a framework approach. RESULTS: All participants believed that mother's own milk was best for LBW infants. Direct breastfeeding was predominant and feeding expressed breast milk and infant formula were rare. DHM was a new concept for most. Adequate maternal nutrition, lactation support, and privacy in the facility aided breastfeeding and expression, but perceived insufficient milk, limited feeding counseling, and infant immaturity were common barriers. Most believed that DHM uptake could be enabled through community awareness by overcoming misconceptions, safety concerns, and perceived family resistance. CONCLUSION: This study fills an evidence gap in LBW infant feeding practices and their facilitators and barriers in resource-limited settings. LBW infants face unique feeding challenges such as poor latching and tiring at the breast. Similarly, their mothers are faced with numerous difficulties, including attainment of adequate milk supply, breast pain and emotional stress. Lactation support and feeding counseling could address obstacles faced by mothers and infants by providing psychosocial, verbal and physical support to empower mothers with skills, knowledge and confidence and facilitate earlier, more and better breast milk feeding. Findings on DHM are critical to the future development of human milk banks and highlight the need to solicit partnership from stakeholders in the community and health system.

Experiences of peer counsellors in supporting exclusive breastfeeding in southern India: An exploratory qualitative study.

OBJECTIVE: Peer counsellors are effective in addressing a variety of health challenges, including exclusive breastfeeding (EBF). Providing education and support from a person of similar background and experience has been an important adjunct to the practice of health workers for the past 50 years. DESIGN: It is an exploratory qualitative study. POPULATION OR SAMPLE: Twenty-two peer counsellors. SETTING: In-depth Interview in the community. METHODS: To better understand the experiences of these important health workers, we conducted qualitative interviews with 22 peer counsellors who participated in a research study in Belagavi District, Karnataka, India. Transcripts of the interviews were organised and assigned codes by the research team. MAIN OUTCOME MEASURES: Experience of Peer counsellor's role in the community to improve breastfeeding practices. RESULTS: Peer counsellors had a good understanding of the larger study and of their role. Analysis of the transcripts identified three themes: personal satisfaction; the effect on the larger circle of family and community; and ideas for future programming. The positive experiences and the ability of peers to be trained in counselling women around EBF support their use in breastfeeding support and other areas of health education. CONCLUSIONS: The women from the community who served as peer counsellors were enthusiastic and satisfied about their work, which provided them with opportunities to do meaningful community work outside of their household routines. Use of the peer counsellor model to deliver a specific objective like improvement in EBF rates, immunisation or mental health in integration with healthcare providers can help in achieving desired goals.

Lessons learned in implementing the Low Birthweight Infant Feeding Exploration study: A large, multi-site observational study.

OBJECTIVE: Globally, early and optimal feeding practices and strategies for small and vulnerable infants are limited. We aim to share the challenges faced and implementation lessons learned from a complex, mixed methods research study on infant feeding. DESIGN: A formative, multi-site, observational cohort study using convergent parallel, mixed-methods design. SETTING: Twelve tertiary/secondary, public/private hospitals in India, Malawi and Tanzania. POPULATION OR SAMPLE: Moderately low birthweight infants (MLBW; 1.50-2.49 kg). METHODS: We assessed infant feeding and care practices through: (1) assessment of in-facility documentation of 603 MLBW patient charts; (2) intensive observation of 148 MLBW infants during facility admission; and (3) prospective 1-year follow-up of 1114 MLBW infants. Focus group discussions and in-depth interviews gathered perspectives on infant feeding among clinicians, families, and key stakeholders. MAIN OUTCOME MEASURES: The outcomes of the primary study were: (1) To understand the current practices and standard of care for feeding LBW infants; (2) To define and document the key outcomes (including growth, morbidity, and lack of success on mother's own milk) for LBW infants under current practices; (3) To assess the acceptability and feasibility of a system-level Infant and Young Child Feeding (IYCF) intervention and the proposed infant feeding options for LBW infants. RESULTS: Hospital-level guidelines and provision of care for MLBW infants varied across and within countries. In all, 89% of charts had missing data on time to first feed and 56% lacked discharge weights. Among 148 infants observed in-facility, 18.5% were discharged prior to meeting stated weight goals. Despite challenges during COVID, 90% of the prospective cohort was followed until 12 months of age. CONCLUSIONS: Enrolment and follow-up of this vulnerable population required additional effort from researchers and the community. Using a mixed-methods exploratory study allowed for a comprehensive understanding of MLBW health and evidence-based planning of targeted large-scale interventions. Multi-site partnerships in global health research, which require active and equal engagement, are instrumental in avoiding duplication and building a stronger, generalisable evidence base.

Safe infant feeding in healthcare facilities: Assessment of infection prevention and control conditions and behaviors in India, Malawi, and Tanzania.

Infants need to receive care in environments that limit their exposure to pathogens. Inadequate water, sanitation, and hygiene (WASH) environments and suboptimal infection prevention and control practices in healthcare settings contribute to the burden of healthcare-associated infections, which are particularly high in low-income settings. Specific research is needed to understand infant feeding preparation in healthcare settings, a task involving multiple behaviors that can introduce pathogens and negatively impact health. To understand feeding preparation practices and potential risks, and to inform strategies for improvement, we assessed facility WASH environments and observed infant feeding preparation practices across 12 facilities in India, Malawi, and Tanzania serving newborn infants. Research was embedded within the Low Birthweight Infant Feeding Exploration (LIFE) observational cohort study, which documented feeding practices and growth patterns to inform feeding interventions. We assessed WASH-related environments and feeding policies of all 12 facilities involved in the LIFE study. Additionally, we used a guidance-informed tool to carry out 27 feeding preparation observations across 9 facilities, enabling assessment of 270 total behaviors. All facilities had 'improved' water and sanitation services. Only 50% had written procedures for preparing expressed breastmilk; 50% had written procedures for cleaning, drying, and storage of infant feeding implements; and 33% had written procedures for preparing infant formula. Among 270 behaviors assessed across the 27 feeding preparation observations, 46 (17.0%) practices were carried out sub-optimally, including preparers not handwashing prior to preparation, and cleaning, drying, and storing of feeding implements in ways that do not effectively prevent contamination. While further research is needed to improve assessment tools and to identify specific microbial risks of the suboptimal behaviors identified, the evidence generated is sufficient to justify investment in developing guidance and programing to strengthen infant feeding preparation practices to ensure optimal newborn health.

Facility-based care for moderately low birthweight infants in India, Malawi, and Tanzania.

Globally, increasing rates of facility-based childbirth enable early intervention for small vulnerable newborns. We describe health system-level inputs, current feeding, and discharge practices for moderately low birthweight (MLBW) infants (1500-<2500g) in resource-constrained settings. The Low Birthweight Infant Feeding Exploration study is a mixed methods observational study in 12 secondary- and tertiary-level facilities in India, Malawi, and Tanzania. We analyzed data from baseline facility assessments and a prospective cohort of 148 MLBW infants from birth to discharge. Anthropometric measuring equipment (e.g., head circumference tapes, length boards), key medications (e.g., surfactant, parenteral nutrition), milk expression tools, and human milk alternatives (e.g., donor milk, formula) were not universally available. MLBW infants were preterm appropriate-for-gestational age (38.5%), preterm large-for-gestational age (3.4%), preterm small-for-gestational age (SGA) (11.5%), and term SGA (46.6%). The median length of stay was 3.1 days (IQR: 1.5, 5.7); 32.4% of infants were NICU-admitted and 67.6% were separated from mothers at least once. Exclusive breastfeeding was high (93.2%). Generalized group lactation support was provided; 81.8% of mother-infant dyads received at least one session and 56.1% had 2+ sessions. At the time of discharge, 5.1% of infants weighed >10% less than their birthweight; 18.8% of infants were discharged with weights below facility-specific policy [1800g in India, 1500g in Malawi, and 2000g in Tanzania]. Based on descriptive analysis, we found constraints in health system inputs which have the potential to hinder high quality care for MLBW infants. Targeted LBW-specific lactation support, discharge at appropriate weight, and access to feeding alternatives would position MLBW for successful feeding and growth post-discharge.

Feeding practices and growth patterns of moderately low birthweight infants in resource-limited settings: results from a multisite, longitudinal observational study.

OBJECTIVES: To describe the feeding profile of low birthweight (LBW) infants in the first half of infancy; and to examine growth patterns and early risk factors of poor 6-month growth outcomes. DESIGN: Prospective observational cohort study. SETTING AND PARTICIPANTS: Stable, moderately LBW (1.50 to <2.50 kg) infants were enrolled at birth from 12 secondary/tertiary facilities in India, Malawi and Tanzania and visited nine times over 6 months. VARIABLES OF INTEREST: Key variables of interest included birth weight, LBW type (combination of preterm/term status and size-for-gestational age at birth), lactation practices and support, feeding profile, birthweight regain by 2 weeks of age and poor 6-month growth outcomes. RESULTS: Between 13 September 2019 and 27 January 2021, 1114 infants were enrolled, comprising 4 LBW types. 363 (37.3%) infants initiated early breast feeding and 425 (43.8%) were exclusively breastfed to 6 months. 231 (22.3%) did not regain birthweight by 2 weeks; at 6 months, 280 (32.6%) were stunted, 222 (25.8%) underweight and 88 (10.2%) wasted. Preterm-small-for-gestational age (SGA) infants had 1.89 (95% CI 1.37 to 2.62) and 2.32 (95% CI 1.48 to 3.62) times greater risks of being stunted and underweight at 6 months compared with preterm-appropriate-for-gestational age (AGA) infants. Term-SGA infants had 2.33 (95% CI 1.77 to 3.08), 2.89 (95% CI 1.97 to 4.24) and 1.99 (95% CI 1.13 to 3.51) times higher risks of being stunted, underweight and wasted compared with preterm-AGA infants. Those not regaining their birthweight by 2 weeks had 1.51 (95% CI 1.23 to 1.85) and 1.55 (95% CI 1.21 to 1.99) times greater risks of being stunted and underweight compared with infants regaining. CONCLUSION: LBW type, particularly SGA regardless of preterm or term status, and lack of birthweight regain by 2 weeks are important risk identification parameters. Early interventions are needed that include optimal feeding support, action-oriented growth monitoring and understanding of the needs and growth patterns of SGA infants to enable appropriate weight gain and proactive management of vulnerable infants. TRIAL REGISTRATION NUMBER: NCT04002908.

A training curriculum for an mHealth supported peer counseling program to promote exclusive breastfeeding in rural India.

BACKGROUND: Despite strong evidence about the benefits of exclusive breastfeeding, that is the baby receiving only breast milk, no other foods or liquids, rates have remained relatively unchanged over the past two decades in low- and middle-income countries. One strategy for increasing exclusive breastfeeding is through community-based programs that use peer counselors for education and support. The use of mobile health applications is also gaining increasing applicability in these countries. Minimal information is available about training peer counselors in the use of mobile technologies to support exclusive breastfeeding. The present article describes our curriculum in the state of Karnataka, India for supporting new mothers to exclusively breastfeed using a mobile health application in rural India. METHODS: Twenty-five women from the community surrounding the city of Belgavi, Karnataka, India were trained to be peer counselors and to use a mobile health application to conduct a structured curriculum to support new mothers in exclusive breastfeeding. The three-day interactive training, conducted in March 2018, was based on the WHO breastfeeding course, translated, and adapted to the local culture The curriculum, which included information collected during a formative research process, consisted of eight visits, two during the antenatal period and continuing for six months postpartum. Twelve nursing and obstetric experts validated curriculum content. Pre-post-evaluation of the training focused on breastfeeding knowledge, self-efficacy, skills, and app usability. RESULTS: We observed a significant increase in the mean scores for knowledge (P < 0.0001) and skills (P = 0.0006) from pre- to post-training. Age of the peer counselors and their own breastfeeding experience correlated significantly with the acquisition of knowledge and skills. The mobile health app showed high usability scores. CONCLUSIONS: The culturally adapted curriculum presented here, combined with an mHealth app, can be an important educational strategy for training rural women in the acquisition of exclusive breastfeeding knowledge and skills.

Design, Development, and Testing of BEST4Baby, an mHealth Technology to Support Exclusive Breastfeeding in India: Pilot Study.

BACKGROUND: Exclusive breastfeeding (EBF) at 6 months of age in most low- and middle-income countries, including India, is surprisingly low. There is a relative lack of mobile health apps that specifically focus on leveraging the use of peer counselors (PCs) to support mothers as a means of increasing EBF practices in low- and middle-income countries. OBJECTIVE: This study aimed to design, develop, and test the usability of Breastfeeding Education Support Tool for Baby (BEST4Baby), a mobile health app specifically designed to support PCs in providing in-home breastfeeding counseling support to mothers in rural India on optimal breastfeeding practices. METHODS: A user-centered design process with an agile development methodology was used. The approach involved stakeholders and mothers who were trained to serve as PCs to guide BEST4Baby's design and development, including the app's content and features. PCs were engaged through focus groups with interactive wireframes. During the 24-month pilot study period, we conducted a feasibility test of the BEST4Baby app with 22 PCs who supported home visits with mothers residing in rural India. The intervention protocol required PCs to provide education and follow mothers using the BEST4Baby app, with 9 scheduled home visits from the late prenatal stage to 6 months post partum. BEST4Baby's usability from the PCs' perspective was assessed using the translated System Usability Scale (SUS). RESULTS: The findings of this study align with best practices in user-centered design (ie, understanding user experience, including context with iterative design with stakeholders) to address EBF barriers. This led to the cultural tailoring and contextual alignment of an evidence-based World Health Organization breastfeeding program with an iterative design and agile development of the BEST4Baby app. A total of 22 PCs tested and rated the BEST4Baby app as highly usable, with a mean SUS score of 85.3 (SD 9.1), placing it over the 95th percentile for SUS scores. The approach translated into a highly usable BEST4Baby app for use by PCs in breastfeeding counseling, which also statistically increased EBF practices. CONCLUSIONS: The findings suggest that BEST4Baby was highly usable and accepted by mothers serving as PCs to support other mothers in their EBF practices and led to positive outcomes in the intervention group's EBF rates. The pilot study demonstrated that using the specially designed BEST4Baby app was an important support tool for mothers to serve as PCs during the 9 home visits. TRIAL REGISTRATION: Clinicaltrials.gov NCT03533725; https://clinicaltrials.gov/ct2/show/NCT03533725.

Feasibility, acceptability, and preliminary impact of an mHealth supported breastfeeding peer counselor intervention in rural India.

OBJECTIVE: To evaluate the feasibility of an mHealth-supported breastfeeding peer counselor intervention implemented in rural India and the preliminary impact of the intervention on maternal breastfeeding behaviors, including exclusive breastfeeding (EBF). METHODS: In this quasi-experimental pilot study, participants received either the intervention plus usual care (n = 110) or usual care alone (n = 112). The intervention group received nine in-home visits during and after pregnancy from peer counselors who provided education about and support for EBF and other optimal infant feeding practices and were aided with an mHealth tool. The control group received routine prenatal and postnatal health education. Progress notes and surveys were used to assess feasibility. Logistic regression models were used for between-group comparisons of optimal infant feeding outcomes, including EBF for 6 months. RESULTS: The intervention was delivered as intended, maintained over the study period, and had high acceptability ratings. There were statistically significant differences in all outcomes between groups. The intervention group had a significantly higher likelihood of EBF at 6 months compared to the control group (adjusted odds ratio 3.57, 95% confidence interval 1.80-7.07). CONCLUSION: Integration of mHealth with community-based peer counselors to educate women about EBF is feasible and acceptable in rural India and impacts maternal breastfeeding behaviors.

Breastfeeding in Coronavirus Disease 2019 (COVID-19): Position Statement of Indian Academy of Pediatrics and Infant and Young Child Feeding Chapter.

JUSTIFICATION: Recent research has provided evidence for lack of transmission of SARS-CoV-2 through human milk and breastfeeding. Updating the practice guidelines will help in providing appropriate advice and support regarding breastfeeding during the coronavirus 2019 (COVID-19) pandemic. OBJECTIVES: To provide evidence-based guidelines to help the healthcare professionals to advise optimal breastfeeding practices during the COVID-19 pandemic. PROCESS: Formulation of key questions was done under the chairmanship of President of the IAP. It was followed by review of literature and the recommendations of other international and national professional bodies. Through Infant and Young child (IYCF) focused WhatsApp group opinion of all members was taken. The final document was prepared after the consensus and approval by all members of the committee. RECOMMENDATIONS: The IYCF Chapter of IAP strongly recommends unabated promotion, protection and support to breastfeeding during the COVID-19 pandemic with due precautions.

Mixed-methods, descriptive and observational cohort study examining feeding and growth patterns among low birthweight infants in India, Malawi and Tanzania: the LIFE study protocol.

INTRODUCTION: Ending preventable deaths of newborns and children under 5 will not be possible without evidence-based strategies addressing the health and care of low birthweight (LBW, <2.5 kg) infants. The majority of LBW infants are born in low- and middle-income countries (LMICs) and account for more than 60%-80% of newborn deaths. Feeding promotion tailored to meet the nutritional needs of LBW infants in LMICs may serve a crucial role in curbing newborn mortality rates and promoting growth. The Low Birthweight Infant Feeding Exploration (LIFE) study aims to establish foundational knowledge regarding optimal feeding options for LBW infants in low-resource settings throughout infancy. METHODS AND ANALYSIS: LIFE is a formative, multisite, observational cohort study involving 12 study facilities in India, Malawi and Tanzania, and using a convergent parallel, mixed-methods design. We assess feeding patterns, growth indicators, morbidity, mortality, child development and health system inputs that facilitate or hinder care and survival of LBW infants. ETHICS AND DISSEMINATION: This study was approved by 11 ethics committees in India, Malawi, Tanzania and the USA. The results will be disseminated through peer-reviewed publications and presentations targeting the global and local research, clinical, programme implementation and policy communities. TRIAL REGISTRATION NUMBERS: NCT04002908 and CTRI/2019/02/017475.

Facilitators and challenges to exclusive breastfeeding in Belagavi District, Karnataka, India.

OBJECTIVE: A primary objective of this study was to identify specific facilitators and challenges around exclusive breastfeeding (EBF) in our community in India, from the perspective of breastfeeding mothers and their support networks. METHODS: We conducted eight focus groups incorporating 75 women and their support networks in the Belagavi District, Karnataka State, India. We used a directed content analysis to guide the analysis. RESULTS: The specific facilitator that emerged as a theme, broad support for and knowledge about breastfeeding on the individual, family and community levels, was a seeming contraction to the identified specific challenge, the paradox of the common practice of supplemental feeds. CONCLUSIONS: Despite voicing strong support for and knowledge about EBF, participants were familiar with a variety of supplemental feeding practices in their communities. In place of universal condemnation of all supplemental feeding, policy makers might consider strategies to address the most potentially dangerous of these practices.

Helping Babies Breathe (HBB) training: What happens to knowledge and skills over time?

BACKGROUND: The first minutes after birth are critical to reducing neonatal mortality. Helping Babies Breathe (HBB) is a simulation-based neonatal resuscitation program for low resource settings. We studied the impact of initial HBB training followed by refresher training on the knowledge and skills of the birth attendants in facilities. METHODS: We conducted HBB trainings in 71 facilities in the NICHD Global Network research sites (Nagpur and Belgaum, India and Eldoret, Kenya), with a 6:1 ratio of facility trainees to Master Trainers (MT). Because of staff turnover, some birth attendants (BA) were trained as they joined the delivery room staff, after the initial training was completed (catch-up initial training). We compared pass rates for skills and knowledge pre- and post- initial HBB training and following refresher training among active BAs. An Objective Structured Clinical Examination (OSCE) B tested resuscitation skill retention by comparing post-initial training performance with pre-refresher training performance. We identified factors associated with loss of skills in pre-refresher training performance using multivariable logistic regression analysis. Daily bag and mask ventilation practice, equipment checks and supportive supervision were stressed as part of training. RESULTS: One hundred five MT (1.6 MT per facility) conducted initial and refresher HBB trainings for 835 BAs; 76% had no prior resuscitation training. Initial training improved knowledge and skills: the pass percentage for knowledge tests improved from 74 to 99% (p < 0.001). Only 5% could ventilate a newborn mannequin correctly before initial training but 97% passed the post-initial ventilation training test (p < 0.0001) and 99% passed the OSCE B resuscitation evaluation. During pre-refresher training evaluation, a mean of 6.7 (SD 2.49) months after the initial training, 99% passed the knowledge test, but the successful completion rate fell to 81% for the OSCE B resuscitation skills test. Characteristics associated with deterioration of resuscitation skills were BAs from tertiary care facilities, no prior resuscitation training, and the timing of training (initial vs. catch-up training). CONCLUSIONS: HBB training significantly improved neonatal resuscitation knowledge and skills. However, skills declined more than knowledge over time. Ongoing skills practice and monitoring, more frequent retesting, and refresher trainings are needed to maintain neonatal resuscitation skills. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01681017 ; 04 September 2012, retrospectively registered.

A pre-post study of a multi-country scale up of resuscitation training of facility birth attendants: does Helping Babies Breathe training save lives?

BACKGROUND: Whether facility-based implementation of Helping Babies Breathe (HBB) reduces neonatal mortality at a population level in low and middle income countries (LMIC) has not been studied. Therefore, we evaluated HBB implementation in this context where our study team has ongoing prospective outcome data on all pregnancies regardless of place of delivery. METHODS: We compared outcomes of birth cohorts in three sites in India and Kenya pre-post implementation of a facility-based intervention, using a prospective, population-based registry in 52 geographic clusters. Our hypothesis was that HBB implementation would result in a 20 % decrease in the perinatal mortality rate (PMR) among births ≥1500 g. RESULTS: We enrolled 70,704 births during two 12-month study periods. Births within each site did not differ pre-post intervention, except for an increased proportion of <2500 g newborns and deliveries by caesarean section in the post period. There were no significant differences in PMR among all registry births; however, a post-hoc analysis stratified by birthweight documented improvement in <2500 g mortality in Belgaum in both registry and in HBB-trained facility births. No improvement in <2500 g mortality measures was noted in Nagpur or Kenya and there was no improvement in normal birth weight survival. CONCLUSIONS: Rapid scale up of HBB training of facility birth attendants in three diverse sites in India and Kenya was not associated with consistent improvements in mortality among all neonates ≥1500 g; however, differential improvements in <2500 g survival in Belgaum suggest the need for careful implementation of HBB training with attention to the target population, data collection, and ongoing quality monitoring activities. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov: NCT01681017 .

Home-Based Early Intervention and the Influence of Family Resources on Cognitive Development.

OBJECTIVE: To investigate whether early developmental intervention (EDI) can positively affect the trajectories of cognitive development among children from low-resource families. METHODS: Longitudinal analyses were conducted of data from 293 children in the Brain Research to Ameliorate Impaired Neurodevelopment Home-based Intervention Trial, a randomized controlled trial of a home-based EDI program, to examine trajectories of Bayley Scales of Infant Development-Second Edition Mental Development Index (MDI) scores from 12 to 36 months of age among young children from high- and low-resource families in 3 low- to middle-resource countries. RESULTS: A 3-way interaction among family resources, intervention group, and age was statistically significant after controlling for maternal, child, and birth characteristics (Wald χ(2)(1) = 9.41, P = .002). Among children of families with high resources, both the intervention and control groups had significant increases in MDI scores over time (P < .001 and P = .002, respectively), and 36-month MDI scores for these 2 groups did not differ significantly (P = .602). However, in families with low resources, the EDI group displayed greater improvement, resulting in significantly higher 36-month MDI scores than the control group (P < .001). In addition, the 36-month MDI scores for children in families with low resources receiving EDI did not differ significantly from children from high-resource families in either the EDI (P = .509) or control (P = .882) groups. CONCLUSIONS: A home-based EDI during the first 3 years of life can substantially decrease the developmental gap between children from families with lower versus higher resources, even among children in low- to middle-resource countries.

Development of a 12 month screener based on items from the Bayley II Scales of Infant Development for use in Low Middle Income countries.

OBJECTIVES: The purpose of the current study was to adapt the Bayley Scales of Infant Development II for use as a screening measure that could be used by health care professionals in Low Middle Income (LMI) countries with 12 month old infants to determine if they needed further assessment and early intervention. METHODS: The adaptations were made as part of a larger study of children participating in a home-based early intervention program in India, Pakistan, and Zambia. Using Item Response Theory, a brief 12 month screener, with excellent sensitivity and specificity was identified. RESULTS: The proposed 12 month screener contains 7 mental/cognitive items and 5 motor items. Children who cannot perform more than 3 items on the mental scale (sensitivity 79%, specificity 85%) and/or 3 items on the motor scale (sensitivity 96%, specificity 95%) should be referred for further assessment. CONCLUSION: This screener can reliably be used to determine if a child needs further developmental assessment.

Implementation and evaluation of the Helping Babies Breathe curriculum in three resource limited settings: does Helping Babies Breathe save lives? A study protocol.

BACKGROUND: Neonatal deaths account for over 40% of all under-5 year deaths; their reduction is increasingly critical for achieving Millennium Development Goal 4. An estimated 3 million newborns die annually during their first month of life; half of these deaths occur during delivery or within 24 hours. Every year, 6 million babies require help to breathe immediately after birth. Resuscitation training to help babies breathe and prevent/manage birth asphyxia is not routine in low-middle income facility settings. Helping Babies Breathe (HBB), a simulation-training program for babies wherever they are born, was developed for use in low-middle income countries. We evaluated whether HBB training of facility birth attendants reduces perinatal mortality in the Eunice Kennedy Shriver National Institute of Child Health and Human Development's Global Network research sites. METHODS/DESIGN: We hypothesize that a two-year prospective pre-post study to evaluate the impact of a facility-based training package, including HBB and essential newborn care, will reduce all perinatal mortality (fresh stillbirth or neonatal death prior to 7 days) among the Global Network's Maternal Neonatal Health Registry births ≥1500 grams in the study clusters served by the facilities. We will also evaluate the effectiveness of the HBB training program changing on facility-based perinatal mortality and resuscitation practices. Seventy-one health facilities serving 52 geographically-defined study clusters in Belgaum and Nagpur, India, and Eldoret, Kenya, and 30,000 women will be included. Primary outcome data will be collected by staff not involved in the HBB intervention. Additional data on resuscitations, resuscitation debriefings, death audits, quality monitoring and improvement will be collected. HBB training will include training of MTs, facility level birth attendants, and quality monitoring and improvement activities. DISCUSSION: Our study will evaluate the effect of a HBB/ENC training and quality monitoring and improvement package on perinatal mortality using a large multicenter design and approach in 71 resource-limited health facilities, leveraging an existing birth registry to provide neonatal outcomes through day 7. The study will provide the evidence base, lessons learned, and best practices that will be essential to guiding future policy and investment in neonatal resuscitation. TRIAL REGISTRATION: Trial registration ClinicalTrials.gov Identifier: NCT01681017.

Biofortification of pearl millet with iron and zinc in a randomized controlled trial increases absorption of these minerals above physiologic requirements in young children.

Millet is unusually drought resistant and consequently there is a progressive increase in the use of these grains as a human food staple, especially in large areas of India and sub-Saharan Africa. The purpose of this study was to determine the absorption of iron and zinc from pearl millet biofortified with 2 micronutrients that are typically deficient in nonfortified, plant-based diets globally. The study was undertaken in 40 children aged 2 y in Karnataka, India (n = 21 test/19 controls). Three test meals providing ∼84 ± 17 g dry pearl millet flour were fed on a single day for zinc and 2 d for iron between 0900 and 1600 h. The quantities of zinc and iron absorbed were measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets. The mean (± SD) quantities of iron absorbed from test and control groups were 0.67 ± 0.48 and 0.23 ± 0.15 mg/d, respectively (P < 0.001). The quantities of zinc absorbed were 0.95 ± 0.47 and 0.67 ± 0.24 mg/d, respectively (P = 0.03). These data did not include absorption of the modest quantities of iron and zinc contained in snacks eaten before and after the 3 test meals. In conclusion, quantities of both iron and zinc absorbed when iron and zinc biofortified pearl millet is fed to children aged 2 y as the major food staple is more than adequate to meet the physiological requirements for these micronutrients.