ABSTRACT
Objective: To assess the feasibility and safety of coolingasphyxiated neonates using phase changing material baseddevice across different neonatal intensive care units in India.Design: Multi-centric uncontrolled clinical trial.Setting: 11 level 3 neonatal units in India from November 2014 toDecember 2015.Participants: 103 newborn infants with perinatal asphyxia,satisfying pre-defined criteria for therapeutic hypothermia.Intervention: Therapeutic hypothermia was provided usingphase changing material based device to a target temperature of33.5±0.5oC, with a standard protocol. Core body temperature wasmonitored continuously using a rectal probe during the coolingand rewarming phase and for 12 hours after the rewarming wascomplete.Outcome measures: Feasibility measure - Time taken to reachtarget temperature, fluctuation of the core body temperatureduring the cooling phase and proportion of temperaturerecordings outside the target range. Safety measure - adverseevents during coolingResults: The median (IQR) of time taken to reach targettemperature was 90 (45, 120) minutes. The mean (SD) deviationof temperature during cooling phase was 33.5 (0.39) ºC.Temperature readings were outside the target range in 10.8%(5.1% of the readings were <33oC and 5.7% were >34oC). Mean(SD) of rate of rewarming was 0.28 (0.13)oC per hour. Thecommon adverse events were shock/ hypotension (18%),coagulopathy (21.4%), sepsis/probable sepsis (20.4%) andthrombocytopenia (10.7%). Cooling was discontinued before 72hours in 18 (17.5%) babies due to reasons such as hemodynamicinstability/refractory shock, persistent pulmonary hypertension orbleeding. 7 (6.8%) babies died during hospitalization.Conclusion: Using phase changing material based coolingdevice and a standard protocol, it was feasible and safe to providetherapeutic hypothermia to asphyxiated neonates across differentneonatal units in India. Maintenance of target temperature wascomparable to standard servo-controlled equipment.
ABSTRACT
Objectives: To test the efficacy of oral sucrose in reducing pain/ stress during echocardiography as estimated by Premature Infant Pain Profile score. Design: Double-blind, parallel-group, randomized control trial. Setting: Tertiary-care neonatal care unit located in Western India. Participants: Neonates with established enteral feeding, not on any respiratory support and with gestational age between 32 and 42 weeks requiring echocardiography. Interventions: Neonates in intervention group received oral sucrose prior to echocardiography. Main outcome measures: Assessment was done using Premature Infant Pain Profile score. Results: There were 104 examinations; 52 in each group. Baseline characteristics like mean gestational age (37.6 vs. 37.1), birth weight (2.20 vs. 2.08), and feeding status (Breastfeeding- 59.6% vs. 44.2%, paladai feeding- 13.5% vs. 13.5%, and gavage feeding- 26.9% vs. 42.3%) were comparable. The mean (SD) premature infant pain profile score was significantly higher in control group [(7.4 (3.78) vs. 5.2 (1.92), P <0.001]. Conclusion: Oral sucrose significantly reduces pain, and is safe to administer to neonates.
ABSTRACT
Objectives: To determine success rate and time taken for intubation by pediatric residents/ fellows. Methods: Prospective observational study among neonates requiring endotracheal intubation. Results: 212 attempts and 118 successful intubations were recorded in 153 videos. An average of 1.93 attempts per successful intubation was observed. Success rate at first attempt and mean time taken by first year, second year, third year residents and fellows were 26% and 51.9; 79% and 39.8; 69% and 40.1; and 67% and 31.5 seconds, respectively. Complications were noted in 77 (36%) attempts. 44 (21%) intubations were performed within 30 seconds. Increase in complications was noted with increase in attempt time beyond 40 seconds. Conclusion: Skill improved from first year to second year. Most intubations exceeded 30 second time limit. There is a need to improve training methodology to ensure intubation time by health personnel does not exceed the expected time limit.