A Clinical trial comparing two devices,T-piece resuscitator and self-inflating bag during neonatal Resuscitation.

Not Applicable

Completed

• Conditions: Health Condition 1: P038- Newborn affected by other specified complications of labor and deliveryHealth Condition 2: null- Resuscitation of Newborn

• Registration Number: CTRI/2010/091/002946
• Lead Sponsor: one

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 90

Inclusion Criteria

All newborn babies requiring PPV at delivery room. They will be stratified in two groups:

1. <34 completed wks (upto 33+6 wks)

2. >34 wks

Exclusion Criteria

Exclusion Criteria:
1.Major congenital abnormalities: anencephaly, encephalocele, meningomyelocele, ectopia vesicae, complex congenital heart disease, and gastroschesis.
2.Meconium stained amniotic fluid.
3.Evidence of chorioamniotis defined as
A. Fever (temp > 37.8º C) plus two or more of the following:
a. Maternal tachycardia. (> 100 beats/ min)
b Fetal tachycardia .(> 160 beats/ min)
c. Uterine tenderness.
d. Malodorous or cloudy amniotic fluid.
e. Maternal WBC count > 15,000 cells/ mm3
B. No other site of infection.
4. Refusal to obtain parental consent.
5. Gestation less than 26 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified