A Clinical Trial on the Effect of Fluid Management on ventilator requirements among Extremely Premature babies

Effect of Fluid restriction and Fluid balance targeting in early postnatal period on Respiratory Outcomes in Preterm infants born less than 29 weeks of Gestation. A Randomized Controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/101386

Enrollment

132

Registered

2026-01-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Health Condition 1: P285- Respiratory failure of newborn

Interventions

Intervention1: Restriction of fluids: Fluids will be started at 100-120 ml/kg/day (less than 25 weeks), at 100 ml/kg/day (25-27 weeks) and 80 ml/kg/day (27 to 29 weeks), fluid adjustments will be done

Eligibility

Inclusion criteria

Inclusion criteria: Infant born less than 29 weeks of gestation and needing mechanical ventilation at or shortly after birth, if on ventilatory support by 24 hours of age.

Exclusion criteria

Exclusion criteria: 1.Infants with major congenital surgical condition. 2.Infants with life threatening congenital genetic anomalies. 3. Infant with refractory shock resistant to inotropes and or steroids. 4. Small for gestational age babies less than 3rd percentile. 5. Out born infants admitted to NICU after 6hours of age. 7. Infants with arterial or venous hematocrit more than 65 percent in first 24 hours.

Design outcomes

Primary

Measure	Time frame
Duration of primary mechanical ventilationTimepoint: four to six weeks of age	—

Secondary

Measure	Time frame
Fluid balanceTimepoint: until 14 days of age;Peak negative fluid balanceTimepoint: until 14 days of age;Total fluid intakeTimepoint: until discharge;Calorie and protein intakeTimepoint: until discharge;Total parenteral nutrition daysTimepoint: until discharge;Time of feed initiationsTimepoint: until discharge;Time to full enteral feedsTimepoint: until discharge;Time to regain birth weightTimepoint: until discharge;Weight gain during hospital stayTimepoint: until discharge;Days of primary invasive ventilationTimepoint: until discharge;Duration of secondary ventilationTimepoint: until discharge;Days of NIMVTimepoint: until discharge;Days of CPAPTimepoint: until discharge;Days of OxygenTimepoint: until discharge;Rates of primary extubation failureTimepoint: within 7 days of extubation;Rate of re-ventilationTimepoint: within 28 days and until discharge;Days of positive pressure ventilation (NIPPV+ NIMV)Timepoint: until discharge;pH, PaCo2, Mean airway rpessure and Fio2 trendsTimepoint: till 6 weeks of age;Neonatal morbidities. A. All cause Mortality B. Shock (requiring inotropes or steroids) C. IVH (grade 3 or more) (Volpe criteria) D. PDA (requiring treatment) Timepoint: until discharge;E. Oliguria (urine output less than 1 ml/kg/h) F. Metabolic bone disease (presence of serum phosphorus less than 5.4 mg/dl and alkaline phosphate more than 900 IU/l), G. Hypotension (blood pressure below the 10th percentile for infants gestational age, postnatal age and weight) H. Hypoglycemia (Blood sugar levels less than 45mg/dl) Timepoint: until discharge;I. Hyperglycemia (Blood sugar levels more than 200mg/dl) J. Hyperbilirubinemia K. Metabolic acidosis (pH less than 7.2) L. Hyponatremia less than 135 mEq/L, M. Severe hyponatremia less than 125 mEq/L N. Hypernatremia more than 145 mEq/L O. Severe hypernatremia more than 155mEq/L, P. Diuretic use and if used, age at start of diuretics and duration Q. Use of postnatal steroids Timepoint: until discharge;R. NEC (d	—

Measure

Time frame

Fluid balanceTimepoint: until 14 days of age;Peak negative fluid balanceTimepoint: until 14 days of age;Total fluid intakeTimepoint: until discharge;Calorie and protein intakeTimepoint: until discharge;Total parenteral nutrition daysTimepoint: until discharge;Time of feed initiationsTimepoint: until discharge;Time to full enteral feedsTimepoint: until discharge;Time to regain birth weightTimepoint: until discharge;Weight gain during hospital stayTimepoint: until discharge;Days of primary invasive ventilationTimepoint: until discharge;Duration of secondary ventilationTimepoint: until discharge;Days of NIMVTimepoint: until discharge;Days of CPAPTimepoint: until discharge;Days of OxygenTimepoint: until discharge;Rates of primary extubation failureTimepoint: within 7 days of extubation;Rate of re-ventilationTimepoint: within 28 days and until discharge;Days of positive pressure ventilation (NIPPV+ NIMV)Timepoint: until discharge;pH, PaCo2, Mean airway rpessure and Fio2 trendsTimepoint: till 6 weeks of age;Neonatal morbidities. A. All cause Mortality B. Shock (requiring inotropes or steroids) C. IVH (grade 3 or more) (Volpe criteria) D. PDA (requiring treatment) Timepoint: until discharge;E. Oliguria (urine output less than 1 ml/kg/h) F. Metabolic bone disease (presence of serum phosphorus less than 5.4 mg/dl and alkaline phosphate more than 900 IU/l), G. Hypotension (blood pressure below the 10th percentile for infants gestational age, postnatal age and weight) H. Hypoglycemia (Blood sugar levels less than 45mg/dl) Timepoint: until discharge;I. Hyperglycemia (Blood sugar levels more than 200mg/dl) J. Hyperbilirubinemia K. Metabolic acidosis (pH less than 7.2) L. Hyponatremia less than 135 mEq/L, M. Severe hyponatremia less than 125 mEq/L N. Hypernatremia more than 145 mEq/L O. Severe hypernatremia more than 155mEq/L, P. Diuretic use and if used, age at start of diuretics and duration Q. Use of postnatal steroids Timepoint: until discharge;R. NEC (d

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Countries

India

Contacts

Public ContactTellis Jessica Sebastian

Surya Childrens Medicare Pvt. Ltd.

tellis.jessica@gmail.com02261538911

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026