CompletedPhase 3

Trial of Late Surfactant to Prevent BPD: A Pilot Study in Ventilated Preterm Neonates Receiving Inhaled Nitric Oxide

United States85 participantsStarted 2008-01

Plain-language summary

The purpose of this study is to determine if the combination of late doses of Infasurf with inhaled nitric oxide will interact to improve the surfactant function and thus the respiratory status and outcome of treated infants.

Who can participate

Age range

7 Days – 14 Days

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: * Less than or equal to 1000 gm. birth weight * Less than or equal to 30 weeks gestational age * Day 7-14 of life * Intubated and mechanically ventilated at any time days 7-14 of life Exclusion Criteria: * Serious congenital malformations * Life expectancy less than 7 days from enrollment * Previous treatment with iNO * Active pulmonary hemorrhage at time of enrollment * Active air leak syndrome at time of enrollment * Bilateral grade IV intracranial hemorrhage prior to enrollment * Less than 48 hours from last clinical dose of early surfactant.

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

SP-B Content

Timeframe: One day after dose

Trial details

NCT IDNCT00569530

SponsorRoberta Ballard

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12

Results submitted2016-02-29

View on ClinicalTrials.gov More Respiratory Distress Syndrome of Prematurity (Surfactant Dysfunction) trials

Who can participate

Age range

7 Days – 14 Days

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.