Higher versus standard breathing pressure during resuscitation of premature babies The PEEP 7 Trial

Comparison of 7 cm H2O versus 5 cm H2O Positive End Expiratory Pressure (PEEP) during Resuscitation of Preterm Infants (more than or equal to 28 weeks): A Randomised Controlled Trial (PEEP-7 Trial) - PEEP 7 trail

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/07/113427

Enrollment

100

Registered

2026-07-06

Start date

Unknown

Completion date

Unknown

Last updated

2026-08-03

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: High PEEP Group: PEEP 7 cm H2O delivered via T-piece resuscitator from initiation of positive pressure ventilation in the delivery room for preterm infants 28 weeks or more gestation Co

Eligibility

Inclusion criteria

Inclusion criteria: Preterm infants with gestational age 28 weeks or more requiring positive pressure ventilation in the delivery room, born at AIIMS Jodhpur, with antenatal informed consent obtained from parent or guardian

Exclusion criteria

Exclusion criteria: Gestational age less than 28 weeks, major congenital anomalies including cardiac pulmonary or chromosomal anomalies, infants requiring immediate intubation, no antenatal consent obtained

Design outcomes

Primary

Measure	Time frame
Rate of endotracheal intubation in the delivery roomTimepoint: At birth, assessed from initiation of resuscitation until 20 minutes of age	—

Secondary

Measure	Time frame
Heart rate responseTimepoint: At 1, 2, 3, 5 and 10 minutes of life;SpO2Timepoint: At 1, 2, 3, 5 and 10 minutes of life;Maximum FiO2 requiredTimepoint: In delivery room within 20 minutes of birth;Need for chest compressionsTimepoint: In delivery room;Air leak including pneumothorax or pulmonary interstitial emphysemaTimepoint: Within 72 hours of birth;Surfactant requirementTimepoint: During hospital stay;Noninvasive ventilation failureTimepoint: Within 72 hours;Bronchopulmonary dysplasiaTimepoint: At 36 weeks postmenstrual age;Intraventricular haemorrhageTimepoint: During hospital stay;MortalityTimepoint: Before hospital discharge	—

Measure

Time frame

Heart rate responseTimepoint: At 1, 2, 3, 5 and 10 minutes of life;SpO2Timepoint: At 1, 2, 3, 5 and 10 minutes of life;Maximum FiO2 requiredTimepoint: In delivery room within 20 minutes of birth;Need for chest compressionsTimepoint: In delivery room;Air leak including pneumothorax or pulmonary interstitial emphysemaTimepoint: Within 72 hours of birth;Surfactant requirementTimepoint: During hospital stay;Noninvasive ventilation failureTimepoint: Within 72 hours;Bronchopulmonary dysplasiaTimepoint: At 36 weeks postmenstrual age;Intraventricular haemorrhageTimepoint: During hospital stay;MortalityTimepoint: Before hospital discharge

—

Countries

India

Contacts

Public ContactDr Satti Satyanarayana Reddy

AIIMS JODHPUR

ssnr973@gmail.com8466075788

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026