Eficacy and safety of restricted fluid therapy in transient tachypnea of the newborn: a randomized controlled study

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 h 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.

Forty-four infants were analyzed. NIPPV duration (36 ± 25 vs. 57 ± 23 h; p = 0.012) and the time to full enteral feeding (65 ± 25 vs. 94 ± 20 h; p < 0.005) were shorter in the RF group. Although the day of discharge was earlier in the RF group, the difference did not reach statistical significance (6.5 ± 1.3 vs. 7.5 ± 2.3 days; p = 0.084). Mean weight loss on postnatal day 5 was higher in the RF group (p < 0.005). No significant differences were observed in urine output, serum electrolytes, or renal function tests. Hypernatremia (ranging from 146 to 150 mmol/L) developed in seven patients (four in the SF group and three in the RF group), and no hypoglycemia or serious adverse events occurred.

Restricted fluid therapy appears safe and effective in TTN infants requiring NIPPV, reducing respiratory support duration and enabling earlier full enteral feeding.

ClinicalTrials.gov, NCT07549945. Registered 23 April 2026, retrospectively registered. The study was conducted between October 2021 and July 2023. During the final stages of the study, the devastating earthquakes that struck southeastern Türkiye in February 2023 caused major disruptions to clinical and academic activities at our institution, contributing to delays in manuscript preparation and trial registration.