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Role of airway clearance for improving the stability of the babies who defecated in the womb and did not breathe at birth

Endotracheal Suctioning versus No Suctioning for Postnatal Stabilization of Non-vigorous Neonates Born through Meconium Stained Liquor: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093590
Enrollment
88
Registered
2025-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

Health Condition 1: P288- Other specified respiratory conditions of newborn

Interventions

Intervention1: Endotracheal suctioning: Non-vigorous neonates delivered through meconium stained liquor will undergo tracheal suctioning under direct laryngoscopy followed by initial steps of resusci

Sponsors

All India Institute of Medical Sciences Rishikesh
Lead Sponsor
Poonam Singh
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Non-vigorous singleton neonates of gestational age equal to or more than 34 weeks delivered through meconium stained liquor

Exclusion criteria

Exclusion criteria: 1. Major congenital malformations 2. Refusal of consent

Design outcomes

Primary

MeasureTime frame
Peripheral oxygen saturationTimepoint: at 5 minutes of life

Secondary

MeasureTime frame
A. Immediate 1. Minute-specific heart rate & peripheral oxygen saturation 2. Fraction of inspired oxygen & number of neonates requiring a 100% oxygen concentration 3. Need for & time to initiate positive pressure ventilation since birth 4. Incidences of procedure related adverse events B. Early 1. Heart rate, respiratory rate, peripheral oxygen saturation, blood pressure & cerebral regional oxygen saturation 2. Incidence of respiratory distress 3. Need & duration of respiratory support 4. Incidence & severity of hypoxic ischemic encephalopathy 5. Death within 72-hours after randomization C. Late 1. Morbidities during hospital stay 2. Final outcome 3. Duration of hospital stay 4. Hammersmith neonatal neurological examination at the time of dischargeTimepoint: at 10 minutes, 1 hour, 72 hours of life & discharge

Countries

India

Contacts

Public ContactArunpadiyan S

All India Institute of Medical Sciences Rishikesh

drpoonamujn@gmail.com8527106059

Outcome results

None listed

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