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A clinical trial to compare two methods of giving artificial breaths namely self-inflating bag and T- piece resuscitator, to a newborn baby who do not cry at birth

Use of self-inflating bag versus T piece resuscitator for resuscitation at the time of birth in preterm neonates—A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079244
Enrollment
136
Registered
2025-01-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Health Condition 1: P914- Neonatal cerebral depression

Interventions

Intervention1: T-piece resuscitator: The T-piece resuscitator, on the other hand, is designed to deliver more controlled and consistent ventilation pressures (both PIP and PEEP) Control Intervention1:

Sponsors

Dr Sandeep Avasarala
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the following should be fulfilled for enrolment: a) Inborn neonates (delivered at NIMS hospital, Jaipur) b) Gestational age 25 to 34 weeks c) Neonates that have not cried after birth and after initial steps require positive pressure ventilation due to apnea/gasping/heart rate less than 100 beats per minute d) Delivered vaginally, through Cesarean or via assisted delivery

Exclusion criteria

Exclusion criteria: Any one of the following a) Major congenital malformation (antenatally diagnosed or visible at birth) b) Refusal of consent by parents

Design outcomes

Primary

MeasureTime frame
Need for delivery room intubationTimepoint: Discharge/ LAMA or Death of baby

Secondary

MeasureTime frame
Several clinical outcomes will be compared in both groups such as : i. Duration of PPV ii. Time to spontaneous breathing iii. Time to achieve HR =100 bpm iv. Saturation at 5 minutes of birth etc.Timepoint: Discharge/ LAMA from hospital or Death

Countries

India

Contacts

Public ContactDr Gunjana Kumar

NIMS University, Jaipur, Rajasthan

gunjanakumar@gmail.com7073077130

Outcome results

None listed

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