Measuring the specific gravity of urine for helping in assessment of how much intravenous fluids are required in newborns admitted to the neonatal intensive care unit

Urine specific gravity measurement for fluid balance in neonates on intravenous fluids admitted to neonatal intensive care unit: an open label randomized controlled trial

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/04/018661

Enrollment

Registered

2019-04-18

Start date

Unknown

Completion date

Unknown

Last updated

2022-11-21

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

Conditions

Health Condition 1: P84- Other problems with newborn

Interventions

Intervention1: Urine specific gravity measurement and using it in addition to standard parameters for daily modification of intravenous fluid therapy: Daily fluid requirement would be adjusted taking

Eligibility

Inclusion criteria

Inclusion criteria: 1. Preterm and term neonates in the NICU requiring IV fluids >= 72 hours 2. Mild to moderate respiratory distress due to various etiologies e.g. respiratory distress syndrome, transient tachypnoea of newborn, meconium aspiration, congenital pneumonia etc. 3. Suspected or probable early onset sepsis without shock (not requiring fluid boluses) 4. Preterm and term growth restricted neonates

Exclusion criteria

Exclusion criteria: 1. Neonates in whom weight measurement would not be possible e.g. persistent pulmonary hypertension on ventilator 2. Severe hypoxemic respiratory failure 3. Shock requiring normal saline bolus or inotropic drug administration 4. Congenital malformations, congenital heart diseases like coarctation of aorta, antenatally diagnosed hydronephrosis, myelomengocoele, gastroschisis etc. 5. Neonates with perinatal asphyxia as their may be underlying acute kidney injury 6. Neonates experiencing hyperglycemia with blood sugar by glucometer >= 150 mg/dl persisting for >= 6 hours

Design outcomes

Primary

Measure	Time frame
To determine the efficacy of urine specific gravity measurement in neonates on intravenous fluids in the Neonatal Intensive Care Unit in maintaining postnatal weight loss within permissible limits.Timepoint: From initiation of intravenous fluid therapy till the discontinuation of intravenous fluids typically between day-7 to day-21 of age	—

Secondary

Measure	Time frame
1. To ascertain the time in days to regain birth weight 2. To ascertain the time in days for discontinuation of IV fluids (time to attain full feeding). 3. Correlation between urine specific gravity with weight loss in preterm and term neonates Timepoint: From initiation of intravenous fluid therapy till the discontinuation of intravenous fluids typically between day-7 to day-21 of age	—

Countries

India

Contacts

Public ContactRuchika Jha

Command Hospital (SC) Pune

docvvt_13@hotmail.com8826118889

Outcome results

None listed

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