Protocol of randomized controlled trial comparing T piece resuscitator versus self-inflating bag for resuscitation in the delivery room in preterm neonates

Background: Neonatal resuscitation is a critical process for a newborn with effective ventilation as its key component. Three manual ventilation devices, including self-inflating bags (SIB), flow-inflating bags (FIB), and T-piece resuscitator (TPR) are recommended for positive pressure ventilation (PPV) in the delivery room. To date, there is insufficient evidence regarding the optimal device for establishing effective ventilation in newborns. This study is planned to compare the effectiveness of TPR and SIB during resuscitation. Methods: This will be a single centre, open-label, randomized controlled trial. Study participants will be preterm ?34 of gestation needing PPV at birth as per NRP algorithm. Newborns will be randomly assigned to two groups (TPR or SIB). SpO2 at 2 and 5 min, time to reach heart rate >100/min by pulse oximetry, and duration of PPV will be recorded. Primary outcome is need of delivery room intubation. Intention to treat analysis will be done using STATA version 17.0. A priori defined subgroup for purpose of analysis will be gestation ?30 and 31-34 weeks. Trial will be done as per good clinical practice guidelines. Conclusions: If PPV with TPR is proven to be more efficacious in terms of less delivery room intubation, there would be a way towards finalizing the TPR as primary device for providing PPV during delivery room resuscitation at birth. This study has potential to bring down need of delivery room intubation with less duration of mechanical ventilation and morbidity in form of IVH, BPD and composite outcome of BPD and death. Trial registration: CTRI number: CTRI/2023/01/048660.

Severe Pulmonary Arteriopathy in a Neonate with Congenital Rubella Syndrome and Patent Ductus Arteriosus

Neonates with congenital rubella syndrome (CRS) are known to have associated congenital cardiac malformations. Patent ductusarteriosus (PDA) is one the most common cardiac anomalies associated with CRS. PDA refractory to medical management andassociated with ventilatory dependence is considered for surgical ligation. However, the management of PDA can be challenging in thepresence of underlying lung disease or pulmonary vascular disease. Outcomes after closure in neonates are dependent upon age,weight, nutritional status, pre-operative pulmonary arterial hypertension and presence of chronic lung disease. We present a neonatewith CRS who required surgical PDA closure. The neonate developed severe pulmonary arterial hypertension which led to fatal outcome.The clinical course is corroborated with histo-pathological changes observed on the autopsy of this neonate.

Reducing Healthcare-associated Infections in Neonates by Standardizing and Improving Compliance to Aseptic Non-touch Techniques: A Quality Improvement Approach

Objective: To standardize and improve compliance to Asepticnon-touch techniques (ANTT) for commonly performedprocedures in Neonatal intensive care unit (NICU) throughapplication of Model for improvement, and study its impact onHealthcare-associated infection (HCAI) rates.Design: Quality improvement project utilizing multiple Plan-Do-Study-Act (PDSA) cycles.Setting: Tertiary-care neonatal unit.Participants: All resident doctors and nurses working in neonatalunit were subjects for assessment of compliance to ANTT. Alladmitted neonates staying in hospital for more than 48 hours weresubjects for HCAI data collection.Procedure: Most frequently performed procedures in NICU wereidentified and pictorial Standard Operating Procedures (SOP)were developed. Implementation and uptake was reinforced bymeans of PDSA cycles. Compliance to ANTT was assessed asproportion of components to which adherence was documented.Trend of HCAI rates in unit were analyzed using process controlcharts.Main outcome measure: Change in compliance to ANTT formost frequently performed procedures.Results: Significant improvement in compliance to ANTTpractices was observed, specifically in use of procedure tray/trolley (16% to 49%, P=0.001), iv hub scrubbing (0% to 60%,P=0.001), local skin cleaning (33% to 67%, P=0.004), personalprotective equipment use (55% to 80%, P=0.02) and disposal(27% to 51%, P=0.03), use of non-touch technique (50% to 70%,P=0.001) and reduction in key part contamination (45% to 31%,P=0.03). A modest decrease in HCAI rates was seen in the shortperiod of observation after implementation.Conclusions: Substantial improvements in compliance toaseptic non-touch techniques can be ensured by adopting acombination of initial intensive teaching and sustaining throughmultiple PDSA cycles, targeting specific areas revealed by audits.