Study to compare Upright Self inflating bag with PEEP valve and T-piece resuscitator in resuscitation of Caesarean born infants of gestation age = 28 weeks

Resuscitation using Upright Self inflating bag with PEEP valve versus T-piece resuscitator in Caesarean born infants = 28 weeks: A Non-inferiority RCT - nil

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064214

Enrollment

180

Registered

2024-03-15

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: O758- Other specified complications of labor and delivery

Interventions

Intervention1: PPV given by Upright Self Inflating bag: In neonate who didn’t cry at birth after initial steps, resuscitation (PPV) will be given with Upright Self Inflating Bag with PEEP valve Contro

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women with gestation =28 weeks anticipating caesarean section (Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available)

Exclusion criteria

Exclusion criteria: 1. Condition requiring immediate endotracheal intubation (CDH) 2. Suspected or confirmed major congenital malformation 3. Suspected or confirmed syndromes

Design outcomes

Primary

Measure	Time frame
Duration of PPV (primary outcome)Timepoint: 60 minutes of life	—

Secondary

Measure	Time frame
1. Proportion of newborn babies achieving a Heart rate =100 bpm at 2 minutes of life. 2. Time duration required to reach HR=100bpm 3. Time to reach =90% pre-ductal SpO2 (seconds) 4. Need of oxygen during resuscitation. 5. Maximum FiO2 required 6. Expanded Apgar score at 1, 5 min (10 min, if applicable ) of life 7. Evaluation for HIE using Sarnat and Sarnat staging 8. Need of NICU admission 9. Need of intubation 10. Need of mechanical ventilation 11. Mortality/morbidities (IVH/ air leaks)Timepoint: till 60 minutes of life	—

Measure

Time frame

1. Proportion of newborn babies achieving a Heart rate =100 bpm at 2 minutes of life. 2. Time duration required to reach HR=100bpm 3. Time to reach =90% pre-ductal SpO2 (seconds) 4. Need of oxygen during resuscitation. 5. Maximum FiO2 required 6. Expanded Apgar score at 1, 5 min (10 min, if applicable ) of life 7. Evaluation for HIE using Sarnat and Sarnat staging 8. Need of NICU admission 9. Need of intubation 10. Need of mechanical ventilation 11. Mortality/morbidities (IVH/ air leaks)Timepoint: till 60 minutes of life

—

Countries

India

Contacts

Public ContactDr Neha Panwar

AIIMS, Jodhpur

neerajpgi@yahoo.co.in8003996908

Outcome results

None listed

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