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Restricted Fluid Therapy for Newborn Breathing Problems

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Summary

A randomized clinical trial registered on ClinicalTrials.gov is investigating restricted fluid (RF) therapy versus standard fluid (SF) therapy for term and late preterm infants with transient tachypnea of the newborn (TTN) who require nasal intermittent positive pressure ventilation (NIPPV). Infants are randomized within 2 hours of birth, with primary outcomes measuring NIPPV duration and day of discharge. Secondary outcomes include weight changes, urine output, biochemical parameters, and adverse effect monitoring.

“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.”

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About this source

ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.

What changed

The clinical trial NCT07549945 is registered as a randomized controlled study comparing restricted fluid therapy to standard fluid therapy in neonates with transient tachypnea of the newborn. Eligible participants are term and late preterm infants with TTN requiring NIPPV, randomized within 2 hours of birth. Primary endpoints are NIPPV duration and discharge timing; secondary endpoints include weight, urine output, biochemical markers, and adverse effects. Healthcare providers caring for neonatal respiratory patients should be aware this trial may inform future fluid management protocols for TTN.

Archived snapshot

Apr 24, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

← ClinicalTrials.gov Studies

Restricted Fluid Therapy for Newborn Breathing Problems

N/A NCT07549945 Kind: NA Apr 24, 2026

Abstract

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.

Conditions: Transient Tachypnea of the Newborn, Fluid Therapy

Interventions: restricted fluid regimen, Standart fluid

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Classification

Agency
NIH
Instrument
Notice
Branch
Executive
Legal weight
Non-binding
Stage
Final
Change scope
Minor

Who this affects

Applies to
Healthcare providers Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Fluid therapy Neonatal respiratory care Clinical research
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Pharmaceuticals Medical Devices

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