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Method of Feeding of Very Small Newborns

Full Volume Feeding versus Small Volume Feeding in Very Low Birth Weight Newborns: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/023683
Enrollment
232
Registered
2020-03-02
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

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

Conditions

Health Condition 1: P059- Newborn affected by slow intrauterine growth, unspecified

Interventions

Intervention1: Full Volume Feeding: Age ml/kg/day D1 80 D2 100 D3 120 D4 140 D5 160 D6 180 D7 180-200 Control Intervention1: Small Volume Feeding: Age ml/kg/day D1 20 D2 40

Sponsors

Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Birth weight between 1000-1499 g

Exclusion criteria

Exclusion criteria: 1.Hemodynamic instability 2.Delivery room resuscitation >1 minute accompanied by neonatal encephalopathy 3.Inability to feed orally due to severe respiratory distress or sickness 4.Reversal of end-diastolic flow on maternal ultrasound 5.Major congenital malformation 6.Failure to obtain informed consent

Design outcomes

Primary

MeasureTime frame
Incidence of extrauterine growth restriction defined as growth parameters (weight, length, head circumference) for postmenstrual age below or equal to 10th centile (Z score below -1.28) as per Intergrowth 21st referenceTimepoint: Hospital discharge

Secondary

MeasureTime frame
1. Late onset sepsis, defined as per European Medicines Agency (modified) 2. Feeding intolerance 3. Necrotizing enterocolitis defined as Bells stage 2 or 3 4. Time to regain birth weight 5. Time to achieve full volume feeding 6. Mortality before hospital discharge 7. Duration of hospital stay 8. Rate of exclusive breastfeeding at hospital discharge 9. Physical growth-weight, length and head circumference at hospital discharge, 3 months, 6 months and 1 year Timepoint: Hospital discharge for outcomes 1 to 8 One year for outcome 9

Countries

India

Contacts

Public ContactShivani Deep Singh

Banaras Hindu University

ashokkumar_bhu@hotmail.com9415300370

Outcome results

None listed

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