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Comparing two different levels of PEEP during delivery room resuscitation in preterm babies

Comparison of two levels of positive end expiratory pressure for delivery room resuscitation in preterm neonates of less than 32 weeks’ gestation : a randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/096996
Enrollment
80
Registered
2025-11-06
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P289- Respiratory condition of newborn,unspecified

Interventions

Intervention1: PEEP 7-8 cm of water: PEEP 7-8 cm of water via T piece resuscitator during delivery room resuscitation till stabilisation. Control Intervention1: PEEP 5-6 cm of water: PEEP 5-6 cm of wa

Sponsors

AIIMS Bhopal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Inborn preterm infants less than 32 weeks gestation requiring resuscitation in delivery room.

Exclusion criteria

Exclusion criteria: 1.Antenatally diagnosed major congenital anomalies or chromosomal disorders. 2.Infants born via MTP. 3.Hydrops fetalis or pulmonary hypoplasia. 4.Preterm new born with surgical conditions. 5.Antenatal diagnosis of conditions resulting in poor prognosis. 6.Peri viable new borns

Design outcomes

Primary

MeasureTime frame
1.Incidence of endotracheal intubation within 72 hrs of birth 2.trends of oxygenation(modified oxygenation index SpO2/FiO2) in first 72 hrs of birth 3.Incidence of hypoxic respiratory failure in first 72 hrs of birth in mechanically ventilated new bornTimepoint: At 2,4,6 and then 6 hourly till 72 hours

Secondary

MeasureTime frame
1. Need for surfactant replacement therapy in first 72 hrs. 2.CPAP failure rate in first 72 hrs after CPAP therapy initiation in NICU. 3.Duration of mechanical ventilation. 4.Duration of respiratory support. 5.Duration of oxygen 6.Hemodynamic compromise in the first 72hrs 7.Rates of BPD at 36 weeks PMA. 8.Incidence of airleak syndromes. 9.Preterm mortality & morbidities like IVH 3/4 , NEC ,ROP, PVL, Culture proven sepsis , duration of NICU stay. 10. Delivery room clinical parametersTimepoint: At 2,4,6 & then 6 hourly. 3days, 7 days, 14 days & 28 days or at discharge.

Countries

India

Contacts

Public ContactDr Chetan Khare

AIIMS Bhopal

drchetankhare@gmail.com9843395041

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026