A study comparing liberal versus restricted fluid administration in newborn with respiratory distress after birth.

A Randomized controlled trial comparing restricted vs standard fluid administration in late preterm and term newborn with transient tachypnea of newborn requiring respiratory support

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/01/017125

Enrollment

210

Registered

2019-01-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: P221- Transient tachypnea of newborn

Interventions

Intervention1: intravenous fluid: late preterm and term newborn with TTNB requiring CPAP recieved 40 , 60 and 80 ml/kg of total fluid ) on day 1,2 and 3 respectively Control Intervention1: intravenous

Eligibility

Inclusion criteria

Inclusion criteria: 1. Inborn babies from 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support 2. Outborn babies presenting within 6 hrs of life of gestational age 34 completed wks to 41 6/7 wks fulfilling the definition of TTNB and requiring CPAP as respiratory support 3. Parents of eligible babies giving consent for participation

Exclusion criteria

Exclusion criteria: 1. Presence of air leak 2. Presence of congenital anomalies 3. Diagnosis of other causes of respiratory distress ( MAS, RDS, suspected sepsis, Surgical causes) 4. Perinatal asphyxia

Design outcomes

Primary

Measure	Time frame
Duration of CPAP support in both the groups of babies with TTNB requiring CPAPTimepoint: 72 hrs	—

Secondary

Measure	Time frame
â?¢Incidence of CPAP failure in newborn with TTNB requiring CPAP in standard fluid management and restricted fluid manageent group.Timepoint: 72 hrs;Duration of NICU stay in both the groups of babies with TTNB requiring CPAPTimepoint: 7 days;Incidence of neonatal morbidities ( Hyperbilirubinemia, Hypoglycemia, dehydration )in both the groups of babies with TTNB requiring CPAPTimepoint: 72 hrs	—

Countries

India

Contacts

Public ContactSomnath Pal

Institute of Post Graduate Medical Education and Research

somnathpal1983@gmail.com9903457386

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026