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

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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