Clinical trial comparing the frequency of milk feeding in babies born less than 1kg

Effect of continuous versus intermittent feeding in extremely low birth weight infants- A Randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/12/047946

Enrollment

130

Registered

2022-12-07

Start date

Unknown

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Health Condition 1: P070- Extremely low birth weight newborn

Interventions

Intervention1: Continuous milk feeds: Prescribed volume of milk is administered continuously through an orogastric tube connected to a infusion pump (feed rate set as ml/hour) Milk infusion delivere

Eligibility

Inclusion criteria

Inclusion criteria: Extremely low birth weight infants born at less than 29 weeks of gestation

Exclusion criteria

Exclusion criteria: major congenital anomalies incompatible with life, infants with gastrointestinal surgical conditions, infants with severe hemodynamic instability

Design outcomes

Primary

Measure	Time frame
Postnatal weight gain (in grams/kg/day)Timepoint: from birth to hospital discharge	—

Secondary

Measure	Time frame
Gain in length(cm/wk)during NICU stayTimepoint: from birth to hospital discharge;Gain in head circumference(cm/week)Timepoint: from birth to hospital discharge;All cause mortalityTimepoint: from birth to hospital discharge;Time to reach full enteral feed(160 ml/kg/day)Timepoint: during hospital stay;Time to regain birth weightTimepoint: during hospital stay;Days on parenteral nutritionTimepoint: during hospital stay;Weekly enteral feed intakeTimepoint: from birth to hospital discharge;Days on human milk fortificationTimepoint: from birth to hospital discharge;Days on formula feedsTimepoint: from birth to hospital discharge;Number of days of feed interruptionTimepoint: from birth to hospital discharge;Neonatal morbidities-IVH(grade III or more),PDA requiring treatment,apnea requiring IPPV,hypoglycemia,late onset sepsis(culture positive),NEC(stage II or higher),ROP requiring interventions,BPD,PVLTimepoint: from birth to hospital discharge;Duration of hospital stayTimepoint: from birth to hospital discharge;Metabolic bone diseaseTimepoint: from birth to hospital discharge	—

Measure

Time frame

Gain in length(cm/wk)during NICU stayTimepoint: from birth to hospital discharge;Gain in head circumference(cm/week)Timepoint: from birth to hospital discharge;All cause mortalityTimepoint: from birth to hospital discharge;Time to reach full enteral feed(160 ml/kg/day)Timepoint: during hospital stay;Time to regain birth weightTimepoint: during hospital stay;Days on parenteral nutritionTimepoint: during hospital stay;Weekly enteral feed intakeTimepoint: from birth to hospital discharge;Days on human milk fortificationTimepoint: from birth to hospital discharge;Days on formula feedsTimepoint: from birth to hospital discharge;Number of days of feed interruptionTimepoint: from birth to hospital discharge;Neonatal morbidities-IVH(grade III or more),PDA requiring treatment,apnea requiring IPPV,hypoglycemia,late onset sepsis(culture positive),NEC(stage II or higher),ROP requiring interventions,BPD,PVLTimepoint: from birth to hospital discharge;Duration of hospital stayTimepoint: from birth to hospital discharge;Metabolic bone diseaseTimepoint: from birth to hospital discharge

—

Countries

India

Contacts

Public ContactHaribalakrishna Balasubramanian

Surya Hospitals

doctorhbk@gmail.com912261538911

Outcome results

None listed

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