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Completed

NCT Number: NCT07549945

Restricted Fluid Therapy for Newborn Breathing Problems

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.

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Key information

About this study

Transient tachypnea of the new-born (TTN) is the most common cause of respiratory distress, in term and late preterm infants. The pathophysiological basis of the disease is the inadequate resorption of fetal alveolar fluid (FAF) during the perinatal period. Normally, 10-20 mL/kg of FAF that fills in the alveoli during the fetal period plays a critical role in the development of lungs and maintaining airway patency. An increase in catecholamine and glucocorticoid levels with the onset of birth activates amiloride-sensitive sodium channels and thus facilitates the clearing of FAF through sodium and water absorption. In cesarean sections performed before the onset of labor, insufficient elevation of stress hormones delays the clearance of FAF. This leads to the accumulation of fluid in the interstitial space, alveolar air trapping, and ultimately impaired gas exchange, resulting in the development of TTN symptoms.

TTN presents with tachypnea, grunting, nasal flaring, increase in anterior-posterior chest diameter, and mild hypoxia that start in the first hours following birth. The diagnosis is based on clinical findings and is supported by chest radiography findings. Most cases resolve within a few days with supportive treatment which includes intravenous fluid support, oxygen therapy, and/or non-invasive ventilation (NIV) support. However, some cases may be complicated by persistent pulmonary hypertension or air leakage (pneumothorax, pneumomediastinum) and which may require invasive ventilation support.

Although diuretics, dopamine, nebulized epinephrine and beta-2 agonists have been investigated in the treatment of TTN, current meta-analyses have not demonstrated strong evidence supporting the efficacy of these agents. Recent studies have demonstrated evidence of increased fluid overload in infants with TTN, such as elevated serum NT-proBNP levels and reduced left atrial reservoir strain. Based on this pathophysiological basis, a limited number of studies have evaluated the efficacy of restricted fluid (RF) therapy in TTN. These studies have reported that RF therapy is safe and may shorten the duration of NIV. However, due to very low certainty about the current evidence, RF therapy is not included in the literature as standard approach and the need for further randomized studies is emphasized. Therefore, in the present study, the investigators aimed to evaluate the efficacy and safety of RF therapy, which is a low-risk and feasible approach that may influence the clinical course of TTN.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

restricted fluid regimen

Procedure

The total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks. 40 mL/kg/day in gestational age of ≥37 weeks

Standart fluid

Procedure

70 mL/kg/day in the standart fluid group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks, whereas it was initiated at 60 mL/kg/day in thestandart fluid group for infants with a gestational age of ≥37 weeks.

Primary outcomes

  1. primary outcome

    Time frame: "From enrollment to the end of treatment at 3 mounts"

    Primary outcomes included duration of NIPPV

  2. Primary Outcome

    Time frame: From enrollment to the end of treatment at 3 mounts

    Discharge day,

Secondary outcomes

  1. secondary outcome

    Time frame: "From enrollment to the end of treatment at 8 weeks"

    Changes in body weight in the following days

  2. Secondary Outcome

    Time frame: from the time of recording to 7 days postnatal

    Daily urine output (ml/kg/day) in the following days

  3. Secondary outcome

    Time frame: From enrollment to the end of treatment at 1 weeks"

    Hypoglycemia monitoring (<50 mg/dL)

Sponsors and collaborators

Lead sponsor

Hitit University

Other

Registry information

Official study title

Eficacy and Safety of Restricted Fluid Therapy in Transient Tachypnea of the Newborn: A Randomized Controlled Study

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 24, 2026
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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