Early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy: a multicentre double-blind pilot randomised controlled trial.

OBJECTIVE: To examine the feasibility of early and extended erythropoietin monotherapy after hypoxic ischaemic encephalopathy (HIE). DESIGN: Double-blind pilot randomised controlled trial. SETTING: Eight neonatal units in South Asia. PATIENTS: Neonates (≥36 weeks) with moderate or severe HIE admitted between 31 December 2022 and 3 May 2023. INTERVENTIONS: Erythropoietin (500 U/kg daily) or to the placebo (sham injections using a screen) within 6 hours of birth and continued for 9 days. MRI at 2 weeks of age. MAIN OUTCOMES AND MEASURES: Feasibility of randomisation, drug administration and assessment of brain injury using MRI. RESULTS: Of the 154 neonates screened, 56 were eligible; 6 declined consent and 50 were recruited; 43 (86%) were inborn. Mean (SD) age at first dose was 4.4 (1.2) hours in erythropoietin and 4.1 (1.0) hours in placebo. Overall mortality at hospital discharge occurred in 5 (19%) vs 11 (46%) (p=0.06), and 3 (13%) vs 9 (40.9%) (p=0.04) among those with moderate encephalopathy in the erythropoietin and placebo groups. Moderate or severe injury to basal ganglia, white matter and cortex occurred in 5 (25%) vs 5 (38.5%); 14 (70%) vs 11 (85%); and 6 (30%) vs 2 (15.4%) in the erythropoietin and placebo group, respectively. Sinus venous thrombosis was seen in two (10%) neonates in the erythropoietin group and none in the control group. CONCLUSIONS: Brain injury and mortality after moderate or severe HIE are high in South Asia. Evaluation of erythropoietin monotherapy using MRI to examine treatment effects is feasible in these settings. TRIAL REGISTRATION NUMBER: NCT05395195.

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.

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.