Effect of early sodium supplementation in postnatal weight gain of preterm babies.

Effect of early sodium supplementation on postnatal weight gain at 34 weeks of postmenstrual age in preterm babiesborn between 25 to 31 weeks gestation age : A Double blinded Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/08/020617

Enrollment

104

Registered

2019-08-07

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: P742- Disturbances of sodium balance ofnewborn

Interventions

Intervention1: 15% hypertonic saline: Study drug will be prepared by the pharmacist under strict aseptic conditions using laminar flow by adding analytic sodium to sterile water to make the desired co

Eligibility

Inclusion criteria

Inclusion criteria: 25 + 0 weeks to 30+6 weeks gestation age

Exclusion criteria

Exclusion criteria: 1) major malformations incompatible with life 2) Congenital gastrointestinal anomalies 3) Clinical condition warranting NPO 4) Renal insufficiency or disease states (such as hydrops fetalis) that are characterized by edema. 5) Enrolled infants with most recent serum sodium concentrations >145 mmol/L on day of recruitment were excluded.

Design outcomes

Secondary

Measure	Time frame
Length and head circumference Time to reach birth weight BPD PDA ROP PVL Duration of hospital stay Necrotising enterocolitis Requirement of Nacl for treatment hyponatremia.Timepoint: at 34 weeks of PMA	—

Primary

Measure	Time frame
weight gain /kg/dayTimepoint: at 34 weeks of PMA	—

Countries

India

Contacts

Public ContactPrakash A

SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH CENTRE

draprakash1@gmail.com9791181566

Outcome results

None listed

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