Comparison of Two Pumping Strategies to Improve Exclusive Breastfeeding at Discharge in Mothers of VLBW Infants with Low Milk Output - A Pilot Randomized Controlled Trial.

OBJECTIVES: To compare the effect of two strategies of breast pumping -power pumping (PP) vs. routine pumping (RP) over one week in mothers of very low birth weight (VLBW) infants with low milk output to improve breastfeeding rates at discharge. METHODS: Mothers with low milk output, defined as inability to express sufficient breastmilk to meet the feeding requirements of their infant on or after post-natal day 14, were randomized to receive power pumping vs. routine pumping - once daily for 7 d coupled with routine lactation support and hand expression 3 hourly in both groups. The primary outcome was exclusive breastfeeding at discharge. RESULTS: There was no difference in the two pumping strategies with respect to exclusive breastfeeding rates [61.1% in PP vs. 50% in RP group; (p = 0.477, RR 1.2; 95% CI 0.76 to 2.17)]. Median milk volume pumped in the individual power pumping session on 7th day of intervention was significantly higher than that in the individual routine pumping session on the 7th day (50 mL vs. 27 mL, p = 0.014). The cumulative median milk volume expressed per individual pumping session over the 7 sessions of power pumping was also higher than that with routine pumping (305 mL vs. 213 mL, p = 0.054). CONCLUSIONS: In this pilot trial, expressed milk volume was significantly higher after each individual power pumping session compared to routine pumping. However, the exclusive breastfeeding rates at discharge were similar in the two groups.

Pain and Physiological Stress During Minimally Invasive Surfactant Therapy (MIST) in Very Preterm Infants.

OBJECTIVE: To evaluate the pain or physiological stress caused during minimally invasive surfactant therapy (MIST) to very preterm neonates. METHODS: In this prospective observational study conducted in a tertiary NICU, very preterm neonates were assessed for pain using Premature Infant Pain Profile-Revised (PIPP-R) score before, during and after MIST. Changes in the heart rate and oxygen saturation were also recorded during the procedure. RESULTS: 23 neonates who received MIST were assessed for pain using PIPP-R. Mean (SD) PIPP-R score during MIST was 3.87(1.3), before; 12.83 (1.9), during; and 6.26 (1.0), after the procedure, respectively (all P<0.001). Heart rate and oxygen saturation were also significantly reduced during MIST (P<0.001). CONCLUSION: The high PIPP-R scores during surfactant administration suggest that MIST can cause moderate to severe pain/discomfort and significant physiological stress in very preterm infants.

The dilemma of feeding during the treatment of patent ductus arteriosus with oral ibuprofen in preterm infants ≤30 weeks of gestation-a randomized controlled trial.

OBJECTIVES: To evaluate the effect of minimal enteral feeding (MEN) versus withholding feeding on time to reach full feeds during treatment of hs-PDA with oral ibuprofen in infants ≤30 weeks. STUDY DESIGN: We performed a single-center, randomized control trial of 126 premature infants born ≤30 weeks gestation, <7 days of age with hs-PDA comparing continuation of MEN (n = 64) vs no feeding (n = 62) during treatment. The primary outcome was time to reach a feed volume of 150 ml/kg/day. Secondary outcomes included were episodes of feed intolerance, GI bleed, NEC and other comorbidities. RESULTS: There was no difference in the time to reach full feeds - median age of 16 days in both groups (p = 0.573). Incidence of feed intolerance, NEC and other secondary outcomes were also similar in both groups. CONCLUSIONS: Continuing MEN during treatment of hs-PDA with oral ibuprofen does not decrease time to reach full enteral feeds in very preterm infants.

Ultrasound-Guided Umbilical Venous Catheter Insertion to Reduce Rate of Catheter Tip Malposition in Neonates: A Randomized, Controlled Trial.

OBJECTIVE: To investigate whether ultrasound-guided umbilical venous catheter (UVC) insertion (US group) reduced the rate of malpositioning of the catheter tip compared to the standard method of insertion (SD group). METHODS: In this open-label, randomized, controlled trial, neonates admitted to NICU within the first week of life were randomly assigned to the US group (n = 26) or SD group (n = 27). Neonates with major congenital anomalies of the thorax and abdomen were excluded. The primary outcome was the rate of malpositioning of the catheter tip. RESULTS: The rate of malpositioning of the catheter tip was observed in a significantly lower number of neonates in the US group as compared to the SD group (11/26, 42.3% vs. 20/27, 74%; RR = 0.57, 95% CI: 0.34 to 0.94, p = 0.019). As more of the UVCs were positioned optimally in the first attempt in the US group than SD group, the need for repeated attempts at catheter repositioning was reduced, resulting in reduced procedure time (minutes) [mean (SD), 23.96 (6.42) vs. 30 (1.83); mean difference 6.04 (95% CI: 3.46 to 8.62), p = 0.005]. This also led to a reduction in the additional X-ray exposure in the US group (n = 11) compared to the SD group (n = 20) [95% CI: 3.12 to 44.26; p = 0.020]. CONCLUSION: Ultrasound-guided UVC insertion significantly reduced the rate of catheter tip malposition. It also reduced the number of attempts at catheter manipulation, procedure time, and X-ray exposures. With adequate training, it could be incorporated into routine bedside practice during UVC insertion for optimum placement. TRIAL REGISTRATION: Clinical Trial Registry of India ( www.ctri.nic.in ) CTRI/2021/03/031894.

Improving Early Colostrum Feeding in a Tertiary Neonatal Intensive Care Unit: A Quality Improvement Initiative.

Background and Objective: Colostrum feeding is known for its immune benefits for reduction in nosocomial sepsis, necrotizing enterocolitis, and ventilator-associated pneumonias. Colostrum feeding also helps in improving breastfeeding rates and early discharge of vulnerable neonatal intensive care unit (NICU) babies. The objective of this study was to improve early colostrum feeding/oropharyngeal colostrum administration in a busy tertiary NICU in India. Methods: Multiple plan-do-study-act (PDSA) cycles were conducted from January 2020 to September 2020 to improve early colostrum feeding rates in NICU babies to >60%. We tested change ideas such as training of health care personnel, counseling of mothers and families about importance of colostrum expression and feeding, bedside collection of colostrum, safe transportation of colostrum to the NICU, and electronic data handling. Sustainability of the interventions was studied from October 2020 to March 2021 and data were analyzed. Results: Early colostrum feeding rates improved from a baseline of 4.36-68.21% after six PDSA cycles through 9 months. After counseling of mothers and families of NICU babies, rates of breastfeeding and colostrum feeding improved to 98.8% and 97.11%, respectively. The early breast stimulation and colostrum expression rates also improved to 87.28% and 68.2%, respectively. Early colostrum feeding rate was 87.5% after 6 months through the sustainability phase. Conclusions: Quality improvement interventions significantly improved the rate of early colostrum feeding in sick babies admitted to a busy NICU, and the improvement was sustained for 6 months.

Impact of mother-baby friendly initiative plus approach on improving human milk feeding for neonates in hospital: a quality improvement before-and-after uncontrolled study.

Breastfeeding, use of pasteurised donor human milk when mother's own milk is unavailable and kangaroo mother care have independently proven benefits in improving survival of vulnerable sick babies. A triangulated approach called the Mother Baby Friendly Initiative Plus (MBFI+) model, bringing together the combined benefits of these proven interventions, was used to improve exclusive human milk feeding at health facilities through quality improvement and system strengthening approach. This quality improvement before-and-after uncontrolled study enrolled 5343 term and 278 very low birth weight (VLBW) mother-infant dyads. Pre- and post-intervention data were compared to evaluate effect on feeding-related healthcare processes and outcomes. Primary outcome which was incidence of exclusive human milk feeding during hospital stay, improved from 44 to 64.8% (RR 1.47, 95% CI: 1.40-1.55) among term and from 60.5 to 80.7% (RR: 1.33; 95% CI: 1.12-1.59) among VLBW neonates. Neonates receiving extended KMC improved from 43 to 71.1% (RR: 1.65; 95% CI: 1.30-2.10).Conclusion: MBFI+ approach improved exclusive human milk feeding among term and preterm VLBW neonates. What is Known: • Breastfeeding has immense health benefits to sick preterm neonates admitted in NICU. What is New: • Quality improvement approach can lead to system strengthening and can help overcome hindrances to achieve increased breastfeeding rates.

Hypothermia for moderate or severe neonatal encephalopathy in low-income and middle-income countries (HELIX): a randomised controlled trial in India, Sri Lanka, and Bangladesh.

BACKGROUND: Although therapeutic hypothermia reduces death or disability after neonatal encephalopathy in high-income countries, its safety and efficacy in low-income and middle-income countries is unclear. We aimed to examine whether therapeutic hypothermia alongside optimal supportive intensive care reduces death or moderate or severe disability after neonatal encephalopathy in south Asia. METHODS: We did a multicountry open-label, randomised controlled trial in seven tertiary neonatal intensive care units in India, Sri Lanka, and Bangladesh. We enrolled infants born at or after 36 weeks of gestation with moderate or severe neonatal encephalopathy and a need for continued resuscitation at 5 min of age or an Apgar score of less than 6 at 5 min of age (for babies born in a hospital), or both, or an absence of crying by 5 min of age (for babies born at home). Using a web-based randomisation system, we allocated infants into a group receiving whole body hypothermia (33·5°C) for 72 h using a servo-controlled cooling device, or to usual care (control group), within 6 h of birth. All recruiting sites had facilities for invasive ventilation, cardiovascular support, and access to 3 Tesla MRI scanners and spectroscopy. Masking of the intervention was not possible, but those involved in the magnetic resonance biomarker analysis and neurodevelopmental outcome assessments were masked to the allocation. The primary outcome was a combined endpoint of death or moderate or severe disability at 18-22 months, assessed by the Bayley Scales of Infant and Toddler Development (third edition) and a detailed neurological examination. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, NCT02387385. FINDINGS: We screened 2296 infants between Aug 15, 2015, and Feb 15, 2019, of whom 576 infants were eligible for inclusion. After exclusions, we recruited 408 eligible infants and we assigned 202 to the hypothermia group and 206 to the control group. Primary outcome data were available for 195 (97%) of the 202 infants in the hypothermia group and 199 (97%) of the 206 control group infants. 98 (50%) infants in the hypothermia group and 94 (47%) infants in the control group died or had a moderate or severe disability (risk ratio 1·06; 95% CI 0·87-1·30; p=0·55). 84 infants (42%) in the hypothermia group and 63 (31%; p=0·022) infants in the control group died, of whom 72 (36%) and 49 (24%; p=0·0087) died during neonatal hospitalisation. Five serious adverse events were reported: three in the hypothermia group (one hospital readmission relating to pneumonia, one septic arthritis, and one suspected venous thrombosis), and two in the control group (one related to desaturations during MRI and other because of endotracheal tube displacement during transport for MRI). No adverse events were considered causally related to the study intervention. INTERPRETATION: Therapeutic hypothermia did not reduce the combined outcome of death or disability at 18 months after neonatal encephalopathy in low-income and middle-income countries, but significantly increased death alone. Therapeutic hypothermia should not be offered as treatment for neonatal encephalopathy in low-income and middle-income countries, even when tertiary neonatal intensive care facilities are available. FUNDING: National Institute for Health Research, Garfield Weston Foundation, and Bill & Melinda Gates Foundation. TRANSLATIONS: For the Hindi, Malayalam, Telugu, Kannada, Singhalese, Tamil, Marathi and Bangla translations of the abstract see Supplementary Materials section.

Bleeding duodenal ulcer with ovarian torsion-a rare presentation in neonates.

Massive upper gastrointestinal bleed is an emergency in newborns. Common causes are coagulopathy and thrombocytopenia. Stress-induced duodenal ulcer has also been reported as an unusual cause for massive upper gastrointestinal bleed. Managing such cases requires correct diagnosis and prompt treatment to prevent catastrophic complications. We report a case of bleeding duodenal ulcer probably secondary to ovarian torsion.

Clinical Profile of SARS-CoV-2 Infected Neonates From a Tertiary Government Hospital in Mumbai, India.

OBJECTIVE: To describe the clinical and laboratory profile of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infected neonates. METHODS: This is a review of hospital records, conducted in a tertiary care public hospital. Medical records of neonates born from 1 April, 2020 to 31 May, 2020 were reviewed. Women admitted in labor were screened for SARS-CoV-2 infection based on the guidelines issued by Indian Council for Medical Research. Neonates were tested for SARS-CoV-2 infection once mother tested positive, which was after day 2 of life. Demographic, clinical features, laboratory tests and chest radiographs of SARS-CoV-2 infected neonates were reviewed and neonates were telephonically followed up till the age of 2 months. RESULTS: Out of 1229 mothers, 185 tested positive (15.05%); 12 neonates (6.48%) tested positive for SARS-CoV-2 infection. All neonates were exclusively breastfed. Symptoms, if any, were mild and self-limiting. Serum lactate dehydrogenase and liver enzymes were elevated. All neonates were healthy and thriving well on follow-up. CONCLUSION: SARS-CoV-2 infected neonates are mostly asymptomatic and thrive well on exclusive breastfeeding.

Consensus Statement of Indian Academy of Pediatrics on Early Childhood Development.

JUSTIFICATION: Early Childhood Development (ECD) has lifelong impact on learning, education, productivity, socio-emotional functioning, health and disease. A Consensus Statement for promoting ECD is needed to improve patient care and promote research. PROCESS: Indian Academy of Pediatrics convened a National Consultative Meeting on 20 September, 2019 at Surat to discuss the way forward for pediatricians in ECD and form a consensus advisory statement. Experts from Chapters of Infant and Young Child Feeding, Neurodevelopmental Pediatrics, Neonatology, Growth Development and Behavior, Adolescent Health Academy, Parenting for Peace and UNICEF participated. OBJECTIVES: To formulate, endorse and disseminate a consensus advisory statement of working at current levels of resources and to build future framework for ECD from Indian perspective. CONCLUSIONS: Interventions for ECD should begin from conception to adolescence, prioritized in first 3 years, inclusive and equitable for all, especially for high risk, vulnerable and marginalized families. Pediatric clinics can play a pivotal role as cost effective delivery points for guidance and interventions. Age appropriate approaches, active care giver's involvement, advocacy and integration with different sectors, community and policy makers should be done to enable supportive environment. Research should be promoted into finding cost effective novel scalable interventions.

Goat lung surfactant for treatment of respiratory distress syndrome among preterm neonates: a multi-site randomized non-inferiority trial.

OBJECTIVE: To investigate the safety and efficacy of goat lung surfactant extract (GLSE) compared with bovine surfactant extract (beractant; Survanta®, AbbVie, USA) for the treatment of neonatal respiratory distress syndrome (RDS). STUDY DESIGN: We conducted a double-blind, non-inferiority, randomized trial in seven Indian centers between June 22, 2016 and January 11, 2018. Preterm neonates of 26 to 32 weeks gestation with clinical diagnosis of RDS were randomized to receive either GLSE or beractant. Repeat dose, if required, was open-label beractant in both the groups. The primary outcome was a composite of death or bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age (PMA). Interim analyses were done by an independent data and safety monitoring board (DSMB). RESULT: After the first interim analyses on 5% enrolment, the "need for repeat dose(s) of surfactant" was added as an additional primary outcome and enrolment restricted to intramural births at five of the seven participating centers. Following second interim analysis after 98 (10% of 900 planned) neonates were enroled, DSMB recommended closure of study in view of inferior efficacy of GLSE in comparison to beractant. There was no significant difference in the primary outcome of death or BPD between GLSE group (n = 52) and beractant group (n = 46) (50.0 vs. 39.1%; OR 1.5; 95% CI 0.7-3.5; p = 0.28). The need for repeat dose of surfactant was significantly higher in GLSE group (65.4 vs. 17.4%; OR 9.0; 95% CI 3.5-23.3; p < 0.001). CONCLUSIONS: Goat lung surfactant was less efficacious than beractant (Survanta®) for treatment of RDS in preterm infants. Reasons to ascertain inferior efficacy of goat lung surfactant requires investigation and possible mitigating strategies in order to develop a low-cost and effective surfactant.

A Landscape Analysis of Human Milk Banks in India.

OBJECTIVES: To evaluate the existing status of human milk banks in India with reference to infrastructure, human resources, funding mechanisms, operating procedures and quality assurance. METHODS: A pretested questionnaire was administered to 16 out of 22 human milk banks across India, operational for more than one year prior to commencing the study. RESULTS: 11 (69%) milk banks were in government or charitable hospitals; only 2 (12.5%) were established with government funding. 8 (50%) had a dedicated technician and only 1(6%) had more than five lactation counsellors. Milk was collected predominantly from mothers of sick babies and in postnatal care wards followed by pediatric outpatient departments, camps, satellite centers, and homes. 10 (63%) reported gaps between donor milk demand and supply. 12 (75%) used shaker water bath pasteurizer and cooled the milk manually without monitoring temperature, and 4 (25%) pooled milk under the laminar airflow. 10 (63%) tracked donor to recipient and almost all did not collect data on early initiation, exclusive breastfeeding or human milk feeding. CONCLUSIONS: Our study reports the gaps of milk banking practices in India, which need to be addressed for strengthening them. Gaps include suboptimal financial support from the government, shortage of key human resources, processes and data gaps, and demand supply gap of donor human milk.

A Qualitative Analysis of the Barriers and Facilitators for Breastfeeding and Kangaroo Mother Care Among Service Providers, Mothers and Influencers of Neonates Admitted in Two Urban Hospitals in India.

BACKGROUND: Known interventions like breastfeeding and kangaroo mother care (KMC) can avert a large share of infant deaths. Mother Baby Friendly Initiative Plus (MBFI+) is an integrated approach to ensure exclusive human milk diet through promotion of breastfeeding, KMC, and provision of donor human milk (DHM) to vulnerable neonates lacking mothers' own milk. MATERIALS AND METHODS: Qualitative research was conducted among 56 service recipients including mothers and key influencers and 9 service providers to understand their knowledge, perceptions, and practices on breastfeeding, KMC, DHM, and human milk banks (HMBs) in 2 facilities in India, one with and another without an operational HMB. This article presents the findings on breastfeeding and KMC. RESULTS: Nearly all mothers mentioned that antenatal visits lacked information on breastfeeding. Most were unaware of the recommended duration of exclusive breastfeeding. Most parents knew about the benefits of breast milk and colostrum. Limited staff and privacy in facilities resulted in inadequate breastfeeding and milk expression support to mothers, who found feeding of preterm and low-birth-weight babies challenging. Mothers shared challenges in breastfeeding at home, such as low family support and privacy and burden of household chores. Only those mothers who practiced KMC were aware of its benefits. Few service providers and recipients were comfortable with the practice of wet nursing in the absence of breastfeeding. CONCLUSIONS: MBFI+ is a promising approach to strengthen breastfeeding and KMC. Quality counseling on breastfeeding and milk expression from antenatal period, increasing awareness and training on KMC for mothers, improving infrastructure, addressing staff shortage, and building capacities of hospital staff on MBFI+ are needed.

Understanding Barriers and Facilitators for Human Milk Banking Among Service Providers, Mothers, and Influencers of Preterm and Sick Neonates Admitted at Two Health Facilities in a Metropolitan City in India.

BACKGROUND: Scaling-up human milk banks (HMBs) is a promising solution for saving vulnerable newborns. Exploring perceptions and practices on donor human milk (DHM) and HMBs is essential to strengthen and scale-up an integrated HMB system resting on a model called the "Mother Baby Friendly Initiative Plus" (MBFI+), which includes promoting breastfeeding, encouraging kangaroo mother care, and providing safe DHM to vulnerable babies without access to mother's own milk. MATERIALS AND METHODS: A qualitative research was conducted among 56 service recipients including mothers and key influencers and 9 service providers to understand their perceptions and practices on DHM and HMBs. RESULTS: Service providers opined that DHM is safe and lifesaving for vulnerable babies. Challenges shared were limited supply of DHM because of low awareness on milk donation, shortage of trained staff, and risk of milk contamination. They stated that although most mothers were comfortable in donating milk, few were reluctant to donate milk as they feared shortage of milk for their own babies, or milk expression may cause weakness. Recipient mothers accepted use of DHM as per facility norms but had concerns about donor mothers' health and hygiene and measures for ensuring milk safety. Most grandmothers were resistant toward donating or receiving DHM for their grandchildren. Many fathers were comfortable with donating once they knew it is lifesaving and did not compromise supply for their babies. Service providers shared opportunities for scale-up, like improving awareness and infrastructure, lactation counseling by skilled personnel, supportive hospital environment, and establishing HMBs in every city and district. CONCLUSIONS: Human milk banking should be strengthened as part of the MBFI+ model. For this, behavior change communication targeted at mothers and influencers about breastfeeding and HMB from the antenatal period, capacity-building among service providers, and government ownership is necessary.

Prefeeding Oromotor Stimulation Program for Improving Oromotor Function in Preterm Infants - A Randomized Controlled Trial.

OBJECTIVE: To determine effect of Premature Infant Oral Motor Intervention program on oro-motor function and time to full independent wati spoon feeds in preterm infants. METHODS: 30 preterm infants between 28-32 weeks of gestation on full gavage feeds of 150 mL/kg/day were randomized to receive either pre-feed oro-motor stimulation using Premature Infant Oral Motor Intervention (structured stimulation) or sham intervention (unstructured stimulation). RESULTS: Improvement in mean (SD) Neonatal Oro-Motor Assessment Scale (NOMAS) over 7 days from baseline was significantly higher in the study group infants as compared to control group (9.25 (1.73) vs 4.79 (1.52), P=0.001). Infants in the study group reached full independent wati spoon feeds significantly earlier than the infants in control group (4.0 (0.8) d; vs 6.64 (1.0) d; P=0.001). There was significant increase in weight gain after enrolment in infants in study group compared to those in control group. CONCLUSION: Oral stimulation program improves the oro-motor skills and growth velocity in 28-32 week preterm infants. There is decreased transition time from gavage to full independent feeds by mouth.

Paradoxical Reaction to Midazolam in Preterm Neonates: A Case Series.

Midazolam is a drug belonging to the benzodiazepine group and is used commonly for seizure control as well as preoperative and procedure-related sedation in neonates. Many adverse effects of midazolam have been reported in the past. Paradoxical stimulation of the central nervous system such as restlessness, nightmare, and hallucinations as well as hypomanic behavior has been reported in adults and children. Seizure is a rare adverse effect of midazolam. Cases of myoclonic movements associated with midazolam have been published worldwide; however, none so far have been reported from India. We report two newborns in our Neonatal Unit, who developed myoclonic seizure after the administration of midazolam. Both of these neonates were preterm, require multiple invasive and noninvasive investigations also leads to parent and clinician stress.