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To compare effects of early oral plus tube feed versus only tube feed in terms of achieving feeding tolerance in preterm very low birth weight infants.

A double-blind randomized controlled study to compare effects of both early oral and tube minimal enteral nutrition (OMEN) and only early tube minimal enteral nutrition (TMEN) in terms of achieving feeding tolerance in preterm very low birth weight infants.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/10/010235
Enrollment
100
Registered
2017-10-27
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Preterm very low birth weight neonates Health Condition 2: P073- Preterm [premature] newborn [other] Health Condition 3: P073- Preterm [premature] newborn [other]

Interventions

Intervention1: Mother Milk: â?¢Intervention for Oral Minimal Enteral Nutrition (OMEN) group: Oral minimal enteral nutrition (3 ml/kg/day) by either babyâ??s own motherâ??s milk or donor breast milk wi
either until infants were judged to be ready to tolerate feeds (defined as absence of following any two findings - greenish or altered aspirates, abdominal distention (increase in abdominal girth by 2
either until infants were judged to be ready to tolerate feeds(defined as abse

Sponsors

Deenanath Mangeshkar Hospital and research center
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Preterm ( 2.Very Low Birth Weight Infants (Birth Weight <=1500 g)

Exclusion criteria

Exclusion criteria: 1. Syndromic babies (e.g. Downs syndrome) 2. Gastrointestinal Malformations (e.g. Easophageal atresia, intestinal atresia etc.) 3. Post gastrointestinal or cardiac surgery Inborn Errors of Metabolism 4. Oro Facial Malformation (e.g. Cleft Lip and Palate, Micrognathia / Retrognathia)

Design outcomes

Primary

MeasureTime frame
Time to reach full tube enteral feeds (in days)Timepoint: Till Discharge from NICU

Secondary

MeasureTime frame
Incidence of invasive infection (as determined by culture of bacteria or fungus from bloodTimepoint: Till Discharge from NICU;cerebrospinal fluid, urine or from a normally sterile body space)Timepoint: Till Discharge from NICU;Duration of hospital stay in days (As per DMH NICU policy infants who satisfy following criteria are discharged from NICU (Infants is medically stable on room air for 48 hours with weight 1500 g,consistent weight gain 15 to 20 g/day for 2 consecutive days on oral feeds and mother is confident)Timepoint: Till Discharge from NICU;Growth (Time to regain birth weight and rates of weight gain, linear growth, head growth during hospital stay)Timepoint: Till Discharge from NICU;Necrotizing enterocolitis (confirmed by at least two of the following features: Abdominal radiograph showing pneumatosis intestinalis or gas in the portal venous system or free air in the abdomen or Diagnosis of NEC confirmed at surgery as per current standard protocol in NICU)Timepoint: Till Discharge from NICU

Countries

India

Contacts

Public ContactDr Shilpa Umesh Kalane

Deenanath Mangeshkar Hospital

drshilpakalane@gmail.com

Outcome results

None listed

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