Restricted Fluid Therapy for Newborn Breathing Problems

NCT07549945 | Completed DMC

• 1 other identifier: Elif1453!
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Transient Tachypnea of the Newborn; Fluid Therapy

Keywords

transient tachypnea of the newborn; restricted fluid therapy,; Noninvasive Ventilation

Outcome Measures

Primary Outcomes (2)

• primary outcome

  Primary outcomes included duration of NIPPV

  "From enrollment to the end of treatment at 3 mounts"

• Primary Outcome

  Discharge day,

  From enrollment to the end of treatment at 3 mounts

Secondary Outcomes (3)

• secondary outcome

  "From enrollment to the end of treatment at 8 weeks"

• Secondary Outcome

  from the time of recording to 7 days postnatal

• Secondary outcome

  From enrollment to the end of treatment at 1 weeks"

Study Arms (2)

Restricted Fluid

EXPERIMENTAL

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. The total fluid volume administered on the first day was initiated at 40 mL/kg/day in the RF group for infants with agestational age of ≥37 weeks

Procedure: restricted fluid regimen

Standart Fluid

ACTIVE COMPARATOR

The total fluid volume administered on the first day was initiated at 70 mL/kg/day in the RF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks. 60 mL/kg/day in gestational age of ≥37 weeks

Procedure: Standart fluid

Interventions

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

Restricted Fluid

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.

Standart Fluid

Eligibility Criteria

• Age: 34 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Neonates born at our hospital with a gestational age of ≥34⁰/⁷ weeks who were diagnosed with TTN were included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hitit University: lead

Study Sites (1)

Hitit University Erol Olçok Training and Research Hospital

Çorum, Çorum, 19100, Turkey (Türkiye)

Location

Related Publications (4)

• Gupta N, Bruschettini M, Chawla D. Fluid restriction in the management of transient tachypnea of the newborn. Cochrane Database Syst Rev. 2021 Feb 18;2(2):CD011466. doi: 10.1002/14651858.CD011466.pub2.

  PMID: 33599990 BACKGROUND

• Sardar S, Pal S, Mishra R. A randomized controlled trial of restricted versus standard fluid management in late preterm and term infants with transient tachypnea of the newborn. J Neonatal Perinatal Med. 2020;13(4):477-487. doi: 10.3233/NPM-190400.

  PMID: 32444567 BACKGROUND

• Dehdashtian M, Aramesh MR, Melekian A, Aletayeb MH, Ghaemmaghami A. Restricted versus Standard Maintenance Fluid Volume in Management of Transient Tachypnea of Newborn: A Clinical Trial. Iran J Pediatr. 2014 Oct;24(5):575-80. Epub 2014 Oct 1.

  PMID: 25793064 BACKGROUND

• Stroustrup A, Trasande L, Holzman IR. Randomized controlled trial of restrictive fluid management in transient tachypnea of the newborn. J Pediatr. 2012 Jan;160(1):38-43.e1. doi: 10.1016/j.jpeds.2011.06.027. Epub 2011 Aug 11.

  PMID: 21839467 BACKGROUND

MeSH Terms

Conditions

Transient Tachypnea of the Newborn

Condition Hierarchy (Ancestors)

Respiratory Distress Syndrome, Newborn; Respiratory Distress Syndrome; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Tachypnea; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• İsmail K Gökçe, Assoc.prof

  Hitit University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof

Model Details: Infants with TTN requiring NIPPV were randomized within the first two hours of life to either the RF group or the standard fluid (SF) group using the sealed opaque envelope method. To ensure homogeneous distribution of infants with similar gestational ages between the groups, infants born at 34⁰/₇-36⁶/₇ weeks and those born at ≥37 weeks of gestation were randomized separately using a stratified randomization approach. The total fluid volume administered on the first day was initiated at 50 mL/kg/day in the RF group and 70 mL/kg/day in the SF group for infants with a gestational age of 34⁰/₇-36⁶/₇ weeks, whereas it was initiated at 40 mL/kg/day in the RF group and 60 mL/kg/day in the SF group for infants with a gestational age of ≥37 weeks.

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 24, 2026
• Study Start: October 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: July 31, 2023
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)