This study aimed to compare the Silverman-Andersen score and the Downes score in predicting noninvasive ventilation (NIPPV) failure in preterm and term infants who received NIPPV support due to postnatal respiratory distress, as well as to evaluate the agreement of these scoring systems with other methods used to assess the severity of respiratory distress.
The present study was designed as a prospective, multicenter, observational study conducted with neonates undergoing noninvasive ventilation.
Who can participate
Age range
2 Hours – 12 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:
* Preterm infants born at \>28 weeks of gestation or term infants born at ≥37 weeks of gestation.
* Development of respiratory distress within the first 6 hours after birth, defined as the presence of at least two of the following: Respiratory rate ≥60/min, Subcostal/intercostal retractions, Grunting.
* Persistence of respiratory distress for more than 6 hours.
* Age within the first 12 hours of life.
* Silverman-Andersen score ≥3.
* Receiving NIPPV support.
Exclusion Criteria:
* Major congenital malformations.
* Airway or pulmonary anomalies.
* Cardiovascular or respiratory instability due to sepsis.
* Cyanotic congenital heart disease.
* Severe intraventricular hemorrhage.
* Contraindications for NIPPV therapy (e.g., congenital nasal anomalies, congenital diaphragmatic hernia, abdominal wall defects).
* Requirement of intubation or chest compressions in the delivery room.
* Requirement of intubation within the first hour of life.
* Death within the first 24 hours of life.
* Gestational age ≤28 weeks.
* Diagnosis of air leak syndrome (pneumothorax) prior to initiation of NIPPV therapy.
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
1
To determine the predictive role of the Silverman-Andersen score for noninvasive ventilation failure at 24 and 72 hours of life.
Timeframe: 24 hours and 72 hours after birth
2
To determine the predictive role of the Downes score for noninvasive ventilation failure at 24 and 72 hours of life