Physiological Changes With High-Flow Nasal Cannula
United States80 participantsStarted 2019-03-15
Plain-language summary
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
Who can participate
Age range
23 Weeks – 28 Weeks
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:
* 23 to 28+6 weeks gestational age at birth
* Corrected gestational age less than or equal to 30 weeks
* Over 72 hours of life
* Stable on Nasal CPAP of 5-7cm H20
* Hemodynamically stable
* Tolerating routine handling
* Nares size appropriate for Fisher \& Paykel Optiflow Jr 2 HFNC size XS or small
* Successfully extubated for 12 hours after administration of surfactant
* Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg
* Transcutaneous monitoring in place
* Stable blood gas (pH\>/= 7.25 and PaCO2 \<60 mmHg torr)
Exclusion Criteria:
* Prior pneumothorax or evidence of pulmonary interstitial emphysema.
* Prior or current pulmonary hemorrhage
* Congenital airway malformations
* Major cardiopulmonary malformations
* Congenital Diaphragmatic hernia or untreated bowel obstruction
* Poor respiratory drive unresponsive to CPAP therapy
* Requirement of a nCPAP of \>8 cmH20 or FiO2 \> 0.3 to maintain oxygen saturations between 90-95 percent.
* Receiving positive pressure breaths or SIPAP on prongs
* Conflicting clinical trial
* Clinically unstable per physician discretion
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.
1This trial studied how high-flow nasal cannula affects lung function in premature babies using a technology called electrical impedance tomography — can you explain what that test involves and whether it would have been safe or comfortable for a premature infant?
2Since this trial has already been completed and was measuring how much of the lung was not being ventilated, have the results been published, and if so, what did they show about how well high-flow nasal cannula works for babies with respiratory distress syndrome?
3This study was listed as 'Phase NA,' which I understand means it was more of an observational or physiological measurement study rather than a treatment trial — does that mean the findings are about understanding how the lungs respond rather than proving a treatment works, and how should I think about that when considering care options for my baby?
4Are there standard treatments already proven for respiratory distress syndrome in premature infants that my baby's care team would consider before or alongside anything informed by studies like this one?
5Since this trial was specifically focused on premature infants with respiratory distress syndrome, how would my baby's gestational age or specific condition affect whether the findings from this study are even relevant to their care?
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
1
Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography
Timeframe: Primary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP.