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PEEP Resuscitation Trial

NCT02971553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-06-12

No results posted yet for this study

Summary

Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.

Conditions

  • Newborn Resuscitation

Interventions

DEVICE

Upright Resuscitator with PEEP

DEVICE

Upright Resuscitator

Sponsors & Collaborators

  • Haydom Lutheran Hospital

    collaborator OTHER

  • Helse Stavanger HF

    lead OTHER_GOV

Principal Investigators

  • Hussein Kidanto, MD, PhD · Muhimibili National Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Tanzania

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02971553 on ClinicalTrials.gov