WithdrawnNot Applicable

nHFOV Versus Invasive Conventional Ventilation for Preterm Neonates With Respiratory Distress Syndrome

Pakistan0Started 2021-06-30

Plain-language summary

Preterm neonates usually develop respiratory distress syndrome (RDS) for which they need respiratory support, which may be invasive and non-invasive depend on the availability and individual need. Non-invasive is relatively safe but non-invasive high frequency oscillatory ventilation (nHFOV) is not appropriately evaluated in neonates as primary support. So the investigators hypothesized that nHFOV is relatively safe and effective in comparison with invasive ventilation for preterm neonates with RDS.

Who can participate

Age range

1 Hour – 6 Hours

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: * Inborn Preterm Neonates 26-34 weeks gestation admitted to NICU with diagnosis of RDS * Babies who were initially started on High Flow Oxygen Therapy/nCPAP but unable to maintain saturation \> 90% on fio2 of 40% in 1st 6 hours of life. * Capillary PCO2 of \> 70 or arterial PCO2 \> 65 on two repeated sampling within 4 hours * Neonates whose parents consented to participate. Exclusion Criteria: * All preterm babies who are below \< 26 weeks above the 34 weeks of gestation * Preterm neonates (26-34 weeks) with diagnosis of RDS requiring endotracheal intubation within Labor room/Operation Theater or within 1st hour of life for respiratory support. * Preterm Neonates with the gestational age of 26-34 weeks, diagnosed as congenital pneumonia or sepsis. * Patient with poor respiratory drive due to any reason neurological or central causes * Diaphragmatic hernia or any other thoracic anomaly * Pleural effusion unilateral or bilateral * Congenital cystic pulmonary malformation. * Neonates with underlying cyanotic heart disease. * Neonates with acynotic heart disease causing pulmonary edema * Neonates with cleft lip and cleft palate or any other surgical condition.

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

Respiratory Support Escalation

Timeframe: within first 24 hours of intervention

Oxygen Requirement

Timeframe: Within first 24 hours

Weaning from Assigned respiratory support

Timeframe: within 1-2 weeks of respiratory support starting

Trial details

NCT IDNCT04914715

SponsorIndus Hospital and Health Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-30

View on ClinicalTrials.gov More Respiratory Distress Syndrome in Premature Infant trials