Restricted Fluid Therapy for Newborn Breathing Problems
Turkey (Türkiye)50 participantsStarted 2021-10-01
Plain-language summary
Evidence suggests that increased intravascular and interstitial fluid load in neonates with transient tachypnea of the newborn (TTN) may delay the clearance of fetal alveolar fluid (FAF). Restricted fluid (RF) therapy may accelerated FAF clearance and improve outcomes in these infants.
Term and late preterm infants with TTN requiring nasal intermittent positive pressure ventilation (NIPPV) were randomized within first 2 hours after birth to receive either RF or standard fluid (SF) therapy. Primary outcomes were the duration of NIPPV and the day of discharge. Secondary outcomes included changes in weight, urine output, biochemical parameters, and monitoring of potential adverse effects.
Who can participate
Age range
34 Weeks – 42 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:
* Neonates born at our hospital with a gestational age of ≥34⁰/⁷ weeks who were diagnosed with TTN were included in the study.
Exclusion Criteria:
* Infants with severe congenital anomalies, those who required intubation in the delivery room or upon admission to the NICU, infants born through meconium-stained amniotic fluid, perinatally asphyxiated infants, infants with suspected sepsis based on risk factors or clinical findings, and infants diagnosed with TTN who did not require NIV were not included from the study.
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
primary outcome
Timeframe: "From enrollment to the end of treatment at 3 mounts"
2
Primary Outcome
Timeframe: From enrollment to the end of treatment at 3 mounts