CompletedNot Applicable

Comparison Of Respiratory Support After Delivery on Infants Born Before 28 Weeks Gestational Age

Iceland, Lithuania, Norway250 participantsStarted 2016-03

Plain-language summary

Trial purpose: For infants born \<28 weeks of age, can initial respiratory resuscitation with new system (low imposed work of breathing and prongs) reduce the frequency of delivery room intubations compared to standard treatment with T-piece resuscitator system (high imposed work of breathing and face mask)? Trial summary: This is a randomised controlled trial of delivery room intubation rates comparing a new system and T-piece resuscitation system for initial stabilisation of infants born \<28 weeks.

Who can participate

SexALL

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Inclusion criteria

✓. Born \<28 weeks gestational age at a university hospital
✓. Delivery can be vaginal or with caesarean section and steroid prophylaxis to mother can be complete, incomplete or not given

Exclusion criteria

✕. Decision on treatment limitations before randomisation
✕. Decision to intubate infant made before delivery (for example local routine for infants born before 23 weeks GA)
✕. Known airway, pulmonary, cardiac, gastro-intestinal tract malformations
✕. Known neuromuscular disease
✕. No study neonatologist available

What they're measuring

Delivery room intubation or death

Timeframe: 0-30 minutes

Trial details

NCT IDNCT02563717

SponsorBaldvin Jonsson

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-15

View on ClinicalTrials.gov More Respiration; Insufficient or Poor, Newborn trials