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

Comparison of T-piece resuscitator with self-inflating bag during delivery room resuscitation of newborn - a randomized controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2010/091/002946
Enrollment
60
Registered
2010-10-29
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

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

Interventions

Intervention1: T-Piece Resuscitator: Control Intervention1: Self inflating Bag:

Sponsors

None
Lead Sponsor
Dr Satish Saluja, Department Of Neonatology, Sir Ganga Ram Hospital,Rajinder Nagar, Delhi-110060
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: All newborn babies requiring PPV at delivery room. They will be stratified in two groups: 1. 2. >34 wks

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Duration of PPV in neonates resuscitated with self-inflating bag or T-piece resuscitator.Timepoint:—

Secondary

MeasureTime frame
1. Need for intubation at delivery room. 2. APGAR scores at 5 min, 10 min . 3. Occurrence of respiratory distress during first 24 hrs. 4. Severity of respiratory distress assessed by worst Downe?s score, requirement for oxygen, CPAP and mechanical ventilation. 5. Mean and maximum FiO2, MAP requirement. 6. Duration of primary ventilation. 7. Need for surfactant. Timepoint:—

Countries

India

Contacts

Public ContactDr Anup Thakur

NIL

ssaluja@vsnl.com09811047389

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 18, 2026