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Urinary Sodium Guided Supplementation in Preterm Infants Less Than 32 Weeks and Growth Outcomes

Urinary Sodium Guided Sodium Supplementation versus Standard treatment in Preterm Infants less than 32 weeks: Impact on Growth A Randomized Controlled Trial. - USGROW

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/05/111123
Enrollment
80
Registered
2026-05-26
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Health Condition 1: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Intervention arm: Preterm infants less than 32 weeks gestation will receive sodium supplementation guided by weekly spot urinary sodium measurements. Infants with urinary sodium below p

Sponsors

Dr Ujwal
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Gestational age less than or equal to 32 weeks at birth. Chronological age 14 days of life at the time of enrollment. An Outborn neonate admitted within 72 hours (3 days) of life to the NICU at St. John s Medical College Hospital.

Exclusion criteria

Exclusion criteria: Major life threatening congenital anomalies. Structural genitourinary abnormality. Renal dysfunction, defined as serum creatinine more 1.0 mg/dL or an increase of more than or equal to 0.3 mg/dL between the two most recent consecutive measurements immediately prior to initiation of study procedures. Use of diuretics within 48 hours prior to initiation of study procedures. Presence of an ostomy .

Design outcomes

Primary

MeasureTime frame
Change in weight-for-age Z-score: Difference in weight-for-age Z-score (based on Fenton preterm growth charts) from baseline (start of supplementation) to 36 weeks postmenstrual age or discharge, whichever occurs first. Timepoint: Change in weight-for-age Z-score: Difference in weight-for-age Z-score (based on Fenton preterm growth charts) from baseline (start of supplementation) to 36 weeks postmenstrual age or discharge, whichever occurs first.

Secondary

MeasureTime frame
Weight gain velocity (g/kg/day), Average daily increase in body weight (g/kg/day) from initiation of supplementation to study completion. Timepoint: ;Variation in length-for-age and head circumference-for-age Z-scores (Fenton growth charts) between baseline and study completion.Timepoint: ;Incidence of hypernatremia (more than 150 mEq/L) Timepoint: ;Duration of NICU stay (days) :Total number of days from birth until discharge from the NICU.Timepoint:

Countries

India

Contacts

Public ContactDR UJWAL

St Johns Medical College Hospital

drujwalpaeds@gmail.com8904343575

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026