Therapeutic hypothermia for moderate and severe hypoxic ischaemic encephalopathy in newborns using low-cost devices - ice packs and phase changing material.

Background: Different methods have been used for therapeutic hypothermia for neonates with moderate-to-severe hypoxic ischaemic encephalopathy (HIE). As standard cooling devices are expensive, there is a need to establish the safety and efficacy of low-cost devices such as ice packs (IP) and phase changing material (PCM). Aim: To assess the efficacy and safety of therapeutic hypothermia (TH) and the clinico-laboratory profile of neonates who underwent cooling with IP or PCM. Methods: The study was retrospective. TH for moderate-to-severe HIE was initiated with IP between 2012 and 2014 and with PCM (MiraCradleTM) from September 2014. A standard protocol for inclusion and management during TH was used for all newborns. All data were collected by means of a local cooling registry. Results: Sixty-two cooled newborns (IP 29, PCM 33) were included in the study. Mean gestational age was 38.6 (1.7) weeks and mean birthweight 2920.6 g (450.7); 66.1% were inborn and 91.9% had moderate encephalopathy. Mean (SD) core temperature during cooling was 33.47°C (0.33) for PCM and 33.44°C (0.34) for IP. Adverse events observed during TH were thrombocytopenia (54.8%), coagulopathy (30.6%), shock (30.6%), skin changes (12.9%) and persistent pulmonary hypertension (8.1%). Forty-nine infants were discharged, two died and 11 were discharged against medical advice. TH was prematurely stopped in seven newborns with serious adverse events such as disseminated intravascular coagulation (DIC), gangrene and arrhythmia (IP 5, PCM 2). Conclusion: Low-cost devices are safe and effective alternatives for maintaining TH in low-resource settings with adequate monitoring. Abbreviations: DAMA, discharged against medical advice; DIC, disseminated intravascular coagulation; HELIX, Hypothermia for Encephalopathy in Low- and Middle-Income Countries Trial; HIE, hypoxic ischaemic encephalopathy; IP, ice packs; LMIC, low- and middle-income countries; NICHD, National Institute of Child Health and Human Development; PCM, phase changing; TH, therapeutic hypothermia (TH); TOBY, total body hypothermia for neonatal encephalopathy.

Umbilical cord milking in preterm neonates requiring resuscitation: A randomized controlled trial.

OBJECTIVE: To evaluate the effect of cord milking on short term morbidity and hematologic parameters at 6 weeks in preterm neonates requiring resuscitation. METHODS: This trial randomized preterm infants requiring resuscitation to milking group and no milking group. Multiple pregnancy, Rh negative mothers, hydrops, cord abnormalities were excluded. The primary outcome was hemoglobin and serum ferritin at 6 weeks of life. Secondary outcomes were common preterm morbidities and mortality. RESULTS: 60 neonates were included in the study. Infants in the milking group had higher hemoglobin (10.07 g/dl vs 8.9 g/dl; p 0.003) and higher serum ferritin level (244.8 ng/ml vs 148.5 ng/ml; p 0.04) compared to no milking group. CONCLUSIONS: In preterm neonates requiring resuscitation, umbilical cord milking results in higher hemoglobin and ferritin at 6 weeks of life. It can be a used as a placental transfusion strategy in preterm neonates requiring resuscitation with no significant adverse effects. CLINICAL TRIAL REGISTRATION: Clinical trials registry -India CTRI/2015/01/005436, www.ctri.nic.in.

Probiotics for Promoting Feed Tolerance in Very Low Birth Weight Neonates - A Randomized Controlled Trial.

OBJECTIVE: To measure the efficacy of a probiotic formulation on time to reach full enteral feeds in VLBW (very low birth weight) newborns. DESIGN: Blinded randomized control trial. SETTING: A tertiary care neonatal intensive care unit (NICU) in Southern India between August 2012 to November 2013. PARTICIPANTS: 104 newborns with a birth weight of 750-1499 g on enteral feeds. INTERVENTION: Probiotic group (n=52) received a multicomponent probiotic formulation of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum and Saccharomyces boulardii once a day at a dose of 1.25×109 CFU from the time of initiation of enteral feeds till discharge and the control group (n=52) received only breast milk. OUTCOME MEASURE: Time to reach full enteral feeds (150 mL/kg/day). RESULTS: The mean (SD) time to reach full enteral feeding was 11.2 (8.3) days in probiotic vs. 12.7 (8.9) in no probiotic group; (P=0.4), and was not significantly different between the two study groups. There was a trend towards lower necrotizing enterocolitis in the probiotic group (4% vs. 12%). CONCLUSION: Probiotic supplementation does not seem to result in significant improvement of feed tolerance in VLBW newborns.

Effect of early versus delayed cord clamping on hematological status of preterm infants at 6 wk of age.

OBJECTIVE: To compare the effect of early cord clamping (ECC) vs. delayed cord clamping (DCC) on hematocrit and serum ferritin at 6 wk of life in preterm infants. METHODS: This randomized controlled trial was conducted in the delivery room and neonatal intensive care unit of a tertiary hospital. One hundred preterm infants born between 30 (0)/7 and 36 (6)/7 wk were randomized to either early or delayed cord clamping groups. Parental informed consent was obtained prior to the delivery. In the ECC group, the cord was clamped immediately after the delivery of the baby and in the DCC group; the cord was clamped beyond 2 min after the baby was delivered. Hematocrit and serum ferritin at 6 wk of life were the primary outcomes. Incidence of anemia, polycythemia and significant jaundice were the main secondary outcomes. RESULTS: The mean hematocrit (27.3 ± 3.8 % vs. 31.8 ± 3.5 %, p value 0.00) and the mean serum ferritin (136.9 ± 83.8 ng/mL vs. 178.9 ± 92.8 ng/mL, p value 0.037) at 6 wk of age were significantly higher in the infants randomized to DCC group. The hematocrit on day 1 was also significantly higher in the DCC group (50.8 ± 5.2 % vs. 58.5 ± 5.1 %, p value 0.00). The DCC group required significantly longer duration of phototherapy (55.3 ± 40.0 h vs. 36.7 ± 32.6 h, p value 0.016) and had a trend towards higher risk of polycythemia. CONCLUSIONS: Delaying the cord clamping by 2 min, significantly improves the hematocrit value at birth and this beneficial effect continues till at least 2nd mo of life.