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Clinical Trials/CTRI/2020/07/026324
CTRI/2020/07/026324
Completed
未知

A Randomized Controlled Trial of Different Nasal Interfaces on the Safety and efficacy of Nasal Intermittent positive Pressure Ventilation in Preterm newborn

Institute of Post Graduate Medical Education and Research Department of Neonatology0 sites210 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: P22- Respiratory distress of newborn
Sponsor
Institute of Post Graduate Medical Education and Research Department of Neonatology
Enrollment
210
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
April 27, 2021
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
Institute of Post Graduate Medical Education and Research Department of Neonatology

Eligibility Criteria

Inclusion Criteria

  • 1\.Preterm newborn (gestational age of \<37 completed weeks at birth) requiring NIPPV as primary respiratory support within 6 h of birth .Thus any preterm baby having respiratory distress within 6 h of birth, objectified as Silverman score of more than 3, will be eligible for non\-invasive positive pressure ventilation.
  • 2\.Preterm newborn requiring NIPPV after extubation within first 7 days of life.Thus
  • any preterm baby undergoing extubation will also be eligible and will be supported with non\-invasive positive pressure ventilation as per study protocol

Exclusion Criteria

  • 1\.Presence of lethal congenital malformation or suspected chromosomal anomaly
  • 2\.Outborn preterm infants
  • 3\.Contraindications of non\-invasive ventilation (shock requiring inotropes, cleft lip and palate, choanal atresia, severe perinatal asphyxia with APPGAR at 5 min of 3 or less)
  • 4\.Parental refusal of consent for participation in the study
  • 5\.Babies already on any form of non\-invasive ventilation (continuous positive airway pressure or non\-invasive positive pressure ventilation or heated humidified high flow nasal cannula) before randomization. Thus baby who is already on continuous positive airway pressure and require because of continuous positive airway pressure failure will not be included in the study.

Outcomes

Primary Outcomes

Not specified

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