PEEP Resuscitation Trial

NCT ID: NCT02971553

Last Updated: 2019-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

330 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2018-05-31

Brief Summary

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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.

Detailed Description

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Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.

The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.

Conditions

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Newborn Resuscitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Upright Resuscitator with PEEP

Ventilation with the Upright Resuscitator with PEEP

Group Type EXPERIMENTAL

Upright Resuscitator with PEEP

Intervention Type DEVICE

Upright Resuscitator

Ventilation with the Upright Resuscitator (without PEEP)

Group Type ACTIVE_COMPARATOR

Upright Resuscitator

Intervention Type DEVICE

Interventions

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Upright Resuscitator with PEEP

Intervention Type DEVICE

Upright Resuscitator

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.

Exclusion Criteria

* Babies with major deformities not deemed to be viable.
* Missing parental consent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haydom Lutheran Hospital

OTHER

Sponsor Role collaborator

Helse Stavanger HF

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hussein Kidanto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Muhimibili National Hospital

Locations

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Haydom Lutheran Hospital, Research Institute

Haydom, Manyara Region, Tanzania

Site Status

Countries

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Tanzania

References

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Holte K, Ersdal H, Eilevstjonn J, Gomo O, Klingenberg C, Thallinger M, Linde J, Stigum H, Yeconia A, Kidanto H, Stordal K. Positive End-Expiratory Pressure in Newborn Resuscitation Around Term: A Randomized Controlled Trial. Pediatrics. 2020 Oct;146(4):e20200494. doi: 10.1542/peds.2020-0494. Epub 2020 Sep 11.

Reference Type DERIVED
PMID: 32917847 (View on PubMed)

Other Identifiers

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Upright PEEP

Identifier Type: -

Identifier Source: org_study_id

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