PEEP Resuscitation Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02971553
• Date of registration: 17/11/2016
• Prospective Registration: No
• Primary sponsor: Helse Stavanger HF
• Public title: PEEP Resuscitation Trial PEEPrest
• Scientific title: A Randomised Controlled Trial on Positive End-expiratory Pressure (PEEP) During Resuscitation of Non-breathing Neonates
• Date of first enrolment: October 2016
• Target sample size: 330
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02971553
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Tanzania

Contacts

• Name: Hussein Kidanto, MD, PhD
• Affiliation: Muhimibili National Hospital

Key inclusion & exclusion criteria

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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Newborn Resuscitation

Intervention(s)

Device: Upright Resuscitator

Device: Upright Resuscitator with PEEP

Primary Outcome(s)

Delta heart rate (beats/minute) during each ventilation sequence [Time Frame: 10 minutes]

Secondary Outcome(s)

Time to detection of exhaled CO2 above 1% and 4% [Time Frame: Up to 1 hour]

Neonatal outcome dead versus alive [Time Frame: Up to 24 hours]

Time to heart rate above 140 beats/minute [Time Frame: Up to 1 hour]

Mean ariway pressures given [Time Frame: Up to 1 hour]

Time to cessation of ventilation [Time Frame: Up to 1 hour]

Secondary ID(s)

Upright PEEP

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Haydom Lutheran Hospital