Does the 3C (Counselling, Checking and Certification) Initiative Prevent Hypoglycemia Among At-Risk Stable Late Preterm and Term Neonates? - A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether the 3C (Counselling, Checking, Certification) initiative helps in preventing hypoglycemia among at-risk neonates compared to standard care. METHODS: This randomised controlled trial included 222 mother-newborn dyads with risk factors for neonatal hypoglycemia-Small for gestational age (SGA) babies, infants of diabetic mothers (IDM), large for gestational age (LGA) babies and late preterm infants (LPI). They were randomized to two groups. Group A received standard care while mothers in group B were administered 3C intervention. Early initiation of breastfeeding, incidence of neonatal hypoglycemia within 24 h, and exclusive breastfeeding rate at 6 mo were evaluated. RESULTS: Early initiation of breastfeeding was higher in the 3C group compared to standard care group (94.6% vs. 55.9% p <0.001). The incidence of hypoglycemia within 24 h was lower in the intervention group compared to standard care (3.6% vs. 15.3%, p <0.05). However, there was no significant difference in exclusive breastfeeding rates at 6 mo between the two groups (61% and 66% in group A and B respectively). CONCLUSIONS: The 3C intervention decreases the incidence of hypoglycemia among at-risk neonates. Early initiation of breast-feeding is higher among mothers who receive the 3C intervention.

Proteinuria in predicting adverse outcomes in women with severe features of pre-eclampsia from a developing country: A prospective cohort study.

OBJECTIVE: To study the adverse maternal and perinatal outcomes in women with severe pre-eclampsia (SPE) among different ranges of proteinuria. METHODS: This prospective cohort study was conducted in Jawaharlal Institute of Postgraduate Medical Education and Research, India. After obtaining informed written consent, the 202 singleton women fulfilling the criteria of severe features of pre-eclampsia were stratified based on the value of urine protein-creatinine ratio (UPCR) as mild, moderate, severe, and massive proteinuria during pregnancy. Clinical outcomes were assessed and patients were followed up until 12 weeks postpartum to identify persistent proteinuria and hypertension. RESULTS: Of the 202 women with SPE, adverse maternal outcomes were seen in 34.65% (n = 70) and adverse perinatal outcomes in 75.74% (n = 153). The demographic and clinical factors were similar among women with increasing severity of proteinuria, except for mean systolic blood pressure, serum creatinine and total serum protein. UPCR was found to have a significant correlation with composite adverse perinatal outcome (P < 0.001) and individual outcomes of neonatal intensive care unit admission for >48 h (P = 0.01) and neonatal sepsis (P = 0.02) but not adverse maternal outcomes (P = 0.201). The optimum UPCR cutoff for adverse perinatal outcomes was 1.6 (sensitivity, 73.2%; specificity, 52.7%). In addition, 14.85% of the women had a persistently elevated UPCR and 3.96% had hypertension at 3 months postpartum. CONCLUSION: In women with SPE, severe and massive proteinuria were related to composite adverse perinatal outcome but not composite adverse maternal outcome. Moreover, antenatal 24-h proteinuria was significantly associated with persistent proteinuria. Significant proteinuria in women with SPE poses a risk for chronic renal dysfunction, requiring follow-up.

A quality improvement project to improve voluntary milk donation in a human milk bank in South India.

Background: Mother's milk is the ideal food for a neonate. When mother's milk is unavailable for any reason, pasteurised donor human milk (PDHM) is the next best option. This quality improvement (QI) project aimed at improving voluntary donation in a public human milk bank (HMB) in South India. Methods: Between January 2018 and June 2019, the HMB received an average of 15 L of donor milk per month (0.5 L/day). Our aim was to increase voluntary donation by 50% from the baseline over a period of 8 months from July 2019 to March 2020 using QI methods. Two plan-do-study-act (PDSA) cycles were done during the intervention period (4 months). Interventions included the formation of micro teams in postnatal wards to promote exclusive breastfeeding and to liaison with the core QI team. We created a milk expression area in the postnatal ward, counseled postnatal mothers, and addressed supply chain issues like sterile pumping accessories. Results: The average daily voluntary milk donation to HMB increased from 0.83 L/day in the baseline phase to 1.16 and 1.14 L per day in the intervention and postintervention phases, respectively. The mean (SD) monthly donated volumes increased from 28.2 (6.1) L to 34.1 (3.7) L; mean difference (95% CI) 5.9 (0.33-11.4); P = 0.03. The volume of PDHM disbursed from HMB increased from 26.6 (3.2) L/month to 32.2 (9.2) L/month, although not statistically significant (p = 0.15). The number of mothers donating milk did not increase during the study period. Conclusions: A multipronged QI intervention effort focusing on exclusive breastfeeding improved voluntary milk donation in HMB bank. Multiple micro-teams and local networking facilitated the QI initiative.

Kangaroo mother care for preterm or low birth weight infants: a systematic review and meta-analysis.

IMPORTANCE: The Cochrane review (2016) on kangaroo mother care (KMC) demonstrated a significant reduction in the risk of mortality in low birth weight infants. New evidence from large multi-centre randomised trials has been available since its publication. OBJECTIVE: Our systematic review compared the effects of KMC vs conventional care and early (ie, within 24 hours of birth) vs late initiation of KMC on critical outcomes such as neonatal mortality. METHODS: Eight electronic databases, including PubMed®, Embase, and Cochrane CENTRAL, from inception until March 2022, were searched. All randomised trials comparing KMC vs conventional care or early vs late initiation of KMC in low birth weight or preterm infants were included. DATA EXTRACTION AND SYNTHESIS: The review followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and was registered with PROSPERO. MAIN OUTCOMES AND MEASURES: The primary outcome was mortality during birth hospitalization or 28 days of life. Other outcomes included severe infection, hypothermia, exclusive breastfeeding rates, and neurodevelopmental impairment. Results were pooled using fixed-effect and random-effects meta-analyses in RevMan 5.4 and Stata 15.1 (StataCorp, College Station, TX). RESULTS: In total, 31 trials with 15 559 infants were included in the review; 27 studies compared KMC with conventional care, while four compared early vs late initiation of KMC. Compared with conventional care, KMC reduces the risks of mortality (relative risk (RR) 0.68; 95% confidence interval (CI) 0.53 to 0.86; 11 trials, 10 505 infants; high certainty evidence) during birth hospitalisation or 28 days of age and probably reduces severe infection until the latest follow-up (RR 0.85, 95% CI 0.79 to 0.92; nine trials; moderate certainty evidence). On subgroup analysis, the reduction in mortality was noted irrespective of gestational age or weight at enrolment, time of initiation, and place of initiation of KMC (hospital or community); the mortality benefits were greater when the daily duration of KMC was at least 8 hours per day than with shorter-duration KMC. Studies comparing early vs late-initiated KMC demonstrated a reduction in neonatal mortality (RR 0.77, 95% CI 0.66 to 0.91; three trials, 3693 infants; high certainty evidence) and a probable decrease in clinical sepsis until 28-days (RR 0.85, 95% CI 0.76 to 0.96; two trials; low certainty evidence) following early initiation of KMC. CONCLUSIONS AND RELEVANCE: The review provides updated evidence on the effects of KMC on mortality and other critical outcomes in preterm and low birth weight infants. The findings suggest that KMC should preferably be initiated within 24 hours of birth and provided for at least 8 hours daily.

Procalcitonin for Detecting Culture-Positive Sepsis in Neonates: A Prospective, Multicenter Study.

INTRODUCTION: It is unclear if serum procalcitonin (PCT) estimated at sepsis suspicion can help detect culture-positive sepsis in neonates. We evaluated the diagnostic performance of PCT in culture-positive sepsis in neonates. METHODS: This was a prospective study (February 2016 to September 2020) conducted in four level-3 units in India. We enrolled neonates suspected of sepsis in the first 28 days of life. Neonates with birth weight <750 g, asphyxia, shock, and major malformations were excluded. Blood for PCT assay was drawn along with the blood culture at the time of suspicion of sepsis and before antibiotic initiation. The investigators labeled the neonates as having culture-positive sepsis or "no sepsis" based on the culture reports and clinical course. PCT assay was performed by electrochemiluminescence immunoassay, and the clinicians were masked to the PCT levels while assigning the label of sepsis. Primary outcomes were the sensitivity, specificity, and likelihood ratios to identify culture-positive sepsis. RESULTS: The mean birth weight (SD) and median gestation (IQR) were 2,113 (727) g and 36 (32-38) weeks, respectively. Of the 1,204 neonates with eligible cultures, 155 (12.9%) had culture-positive sepsis. Most (79.4%) were culture-positive within 72 h of birth. The sensitivity, specificity, and positive and negative likelihood ratios at 2 ng/mL PCT threshold were 52.3% (95% confidence interval: 44.1-60.3), 64.5% (60.7-68.1), 1.47 (1.23-1.76), and 0.74 (0.62-0.88), respectively. Adding PCT to assessing neonates with 12.9% pretest probability of sepsis generated posttest probabilities of 18% and 10% for positive and negative test results, respectively. CONCLUSION: Serum PCT did not reliably identify culture-positive sepsis in neonates.

Short-term neurodevelopment and growth outcomes of very and moderate preterm Indian infants.

OBJECTIVE: To study the growth and neurodevelopmental outcome of very and moderate preterm infants (VMPT) compared to term appropriate-for-age (term AGA) infants at 18-months corrected age. METHODS: This prospective cohort study enrolled consecutively born 212 VMPT infants and 250 term AGA controls delivered during study period. OUTCOME MEASURES: Major neurodevelopmental impairment (NDI) defined as any one of cerebral palsy, motor (MoDQ) or mental developmental quotient (MoDQ) <70 on Developmental Assessment Scale for Indian infants, visual or hearing impairment, or epilepsy, and growth outcomes. RESULTS: Among 195 VMPT and 240 term AGA infants who completed follow-up, the frequency of major NDI was 12.8% and 2.5% respectively (RR 5.1; 95% CI [2.13-12.19]). Major NDI was higher among infants <28 weeks gestation (39%) and birthweight <1000 grams (27%). A quarter of VMPT infants exhibited wasting and 18% stunting than 7% each among controls. CONCLUSION: VMPT infants had a higher frequency of major NDI and growth failure at 18-months.

Clinical Profile and Outcome of Newborns Discharged Against Medical Advice From a Tertiary Care Centre.

OBJECTIVE: To determine the clinical profile and outcome of neonates discharged against medical advice (DAMA) from the neonatal intensive care unit (NICU) of a tertiary care public hospital. METHODS: We retrieved information from hospital records of infants who had been discharged against medical advice from the NICU between January, 2016 and December, 2020. This was followed by a telephonic interview to document the infant's outcome. RESULTS: Out of the 187 (7.7%) neonates that had left DAMA, 165 case records were available, and 65 (39%) families could be contacted telephonically. Congenital malformations accounted for 96 (58%) of the cases; cardiac malformations accounting for 42 (43.7%). 52 (80%) out of the 65 infants had died after median (IQR) 11 (5-35) days of DAMA, and 13 (20%) were alive at a median (IQR) age of 31 (18.5-31.5) months. Post-DAMA medical care was continued at another health facility in 12 (18%). CONCLUSION: One out of every five infants was alive for a median age of 31 months after having left DAMA. Mechanisms to ensure continuation of care after DAMA need to be explored.

Update to Perinatal-Neonatal Management of COVID-19 Guidelines.

The guidelines for diagnosing and managing perinatal SARS-CoV-2 infection for the Indian context were last updated in May 2020. Newer evidence, the evolution of the pandemic, and its significant impact on mother-infant dyads led us to review and revise the guideline. This article summarizes the salient changes inthe perinatal-neonatal management of COVID-19.

Is SARS-CoV-2 Transmitted Through Breastfeeding?

There are concerns regarding the transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) from mother to child during this COVID pandemic. This descriptive study was done to check the possible transmission of the virus through breastfeeding in the Indian context. RT-qPCR for SARS-CoV-2 was done in breast milk samples from 30 COVID-positive mothers. Paired oropharyngeal swabs of the same neonates were also sent for RT-PCR at 48 h and on day 5 of life. All the breast milk samples were negative for SARS-CoV-2 except one. A repeat sample of breast milk from the same mother was also negative when rechecked the next day. All the paired neonatal oropharyngeal swabs were also negative for SARS-CoV-2. The authors could not find evidence for transmission of SARS-CoV-2 from mother to child through breastmilk in the population studied.

Implementing Family-Centered Care in the Neonatal Intensive Care Unit - A Quality Improvement Initiative.

OBJECTIVE: The present study aims to implement family-centered care (FCC) in neonatal intensive care unit (NICU). FCC facilitates mother-infant bonding with benefits for both families and health system. The authors used quality-improvement (QI) methods to implement FCC in level-2 NICU from an existing baseline of 30% to 80% over a period of 6 mo. METHODS: Using the Institute of Healthcare model for improvement, the authors implemented strategies for family participation in caregiving activities, oral feeding and kangaroo care for neonates admitted in level-2 NICU. Eligibility criteria included the availability of at least one family member, preferably the mother for at least 6 h/d and a stable neonate based on physiological criteria irrespective of gestational age. The key interventions were: (1) adoption of a unit protocol for FCC with expanded visitation hours; (2) parental education through audio-visual aids, and (3) capacity building through training and peer support. RESULT: Between August 2019 and January 2020, 1587 neonates were admitted to the NICU and 505 admitted in level-2 were enrolled. The proportion of eligible mother-infant dyads participating in FCC increased from a baseline of 32% to 44% during intervention and to 66% in the postintervention phase. The number of days per month FCC was tracked increased from 67% in the baseline to 82% in postintervention phase. There was no increase in the incidence of sepsis after implementation of FCC. CONCLUSION: Orientation of parents to FCC using audio-visual aids, provision of hands-on training and peer-support facilitated them to become active participants in their neonates' care.

COVID-19 in Neonates: A Call for Standardized Testing.

The limited evidence on neonatal coronavirus disease (COVID-19) suggests that vertical transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is rare, and most neonates seem to acquire the infection postnatally through respiratory droplets and contact. Testing of neonates with perinatal or postnatal exposure to COVID-19 infection plays a vital role in the early diagnosis, management and institution of infection prevention measures thereby cutting off the chain of epidemic transmission. A recently concluded online neonatal COVID-19 conference conducted by the National Neonatology Forum (NNF) of India and a nationwide online survey pointed to substantial variation in neonatal testing strategies. We, herein, summarize the relevant literature about the incidence and outcomes of neonatal COVID-19 and call for a universal and uniform testing strategy for exposed neonates. We anticipate that the testing strategy put forth in this article will facilitate better management and safe infection prevention measures among all units offering neonatal care in the country.

Perinatal-Neonatal Management of COVID-19 Infection: guidelines of the Federation of Obstetric and Gynaecological Societies of India (FOGSI), National Neonatology Forum of India (NNF), and Indian Academy of Pediatrics (IAP)

During the current rapidly evolving pandemic of COVID-19 infection, pregnant women with suspected or confirmed COVID-19 and their newborn infants form a special vulnerable group that needs immediate attention. Unlike other elective medical and surgical problems for which care can be deferred during the pandemic, pregnancies and childbirths continue. Perinatal period poses unique challenges and care of the mother-baby dyads requires special resources for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period. Process: The GRADE approach recommended by the World Health Organization was used to develop the guideline. A Guideline Development Group (GDG) comprising of obstetricians, neonatologists and pediatricians was constituted. The GDG drafted a list of questions which are likely to be faced by clinicians involved in obstetric and neonatal care. An e-survey was carried out amongst a wider group of clinicians to invite more questions and prioritize. Literature search was carried out in PubMed and websites of relevant international and national professional organizations. Existing guidelines, systematic reviews, clinical trials, narrative reviews and other descriptive reports were reviewed. For the practicequestions, the evidence was extracted into evidence profiles. The context, resources required, values and preferences were considered for developing the recommendations. Objectives: To provide recommendations for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period. Recommendations: A set of twenty recommendations are provided under the following broad headings: 1) pregnant women with travel history, clinical suspicion or confirmed COVID-19 infection; 2) neonatal care; 3) prevention and infection control; 4) diagnosis; 5) general questions.

Perinatal-Neonatal Management of COVID-19 Infection - Guidelines of the Federation of Obstetric and Gynaecological Societies of India (FOGSI), National Neonatology Forum of India (NNF), and Indian Academy of Pediatrics (IAP).

JUSTIFICATION: During the current rapidly evolving pandemic of COVID-19 infection, pregnant women with suspected or confirmed COVID-19 and their newborn infants form a special vulnerable group that needs immediate attention. Unlike other elective medical and surgical problems for which care can be deferred during the pandemic, pregnancies and childbirths continue. Perinatal period poses unique challenges and care of the mother-baby dyads requires special resources for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period. PROCESS: The GRADE approach recommended by the World Health Organization was used to develop the guideline. A Guideline Development Group (GDG) comprising of obstetricians, neonatologists and pediatricians was constituted. The GDG drafted a list of questions which are likely to be faced by clinicians involved in obstetric and neonatal care. An e-survey was carried out amongst a wider group of clinicians to invite more questions and prioritize. Literature search was carried out in PubMed and websites of relevant international and national professional organizations. Existing guidelines, systematic reviews, clinical trials, narrative reviews and other descriptive reports were reviewed. For the practice questions, the evidence was extracted into evidence profiles. The context, resources required, values and preferences were considered for developing the recommendations. OBJECTIVES: To provide recommendations for prevention of transmission, diagnosis of infection and providing clinical care during labor, resuscitation and postnatal period. RECOMMENDATIONS: A set of twenty recommendations are provided under the following broad headings: 1) pregnant women with travel history, clinical suspicion or confirmed COVID-19 infection; 2) neonatal care; 3) prevention and infection control; 4) diagnosis; 5) general questions.

Predictors of Mortality among Neonates with Congenital Diaphragmatic Hernia: Experience from an Inborn Unselected Cohort in India.

OBJECTIVE: To evaluate the clinical profile and predictors of mortality in neonates with congenital diaphragmatic hernia (CDH). METHODS: Demographic and clinical parameters of neonates with congenital diaphragmatic heria (n=37) between January 2014 and October, 2017 were reviewed, and compared among those who survived or expired in hospital. RESULTS: Median (range) gestation and birthweight were 38 (37-39) weeks and 2496 (2044-2889) g, respectively. Persistent pulmonary hypertension (PPHN) was documented in 19 (51%) neonates and 10 (27%) had associated malformations. Surgery could be performed in 18 (49%), overall mortality was 60%. On univariate analysis, low Apgar scores, presence of malformations, PPHN, need for higher initial peak inspiratory pressure/high frequency ventilation, and requirement of a patch for closure were associated with increased mortality. On multivariate analysis, PPHN remained the only significant risk factor [adjusted RR 3.74 (95% CI 1.45-9.68)]. CONCLUSIONS: The survival of infants with CDH is low, and PPHN is an important predictor of mortality.