Skip to main content
OpenTrials
Completed

NCT Number: NCT06076460

Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Infants 27-32 Weeks of Gestation

The objective of the study is to compare the time of attainment of full enteral feeds in preterm neonates between 27-32 weeks of gestation started on early total enteral feeding (ETEF) with those started on conventional enteral feeding (CEF).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Very Preterm Maturity of Infant Enteral Feeding Intolerance

Age range

Up to 1 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lady Hardinge Medical College

New Delhi, National Capital Territory of Delhi, 110001, India

About this study

Enrolled participants will be randomly assigned to one of two study groups: 1) early total enteral feeding (ETEF) or 2) conventional enteral feeding (CEF). Regardless of study group assignment, mother's own breast milk (MOM) is the feed of choice and donor human milk is being offered if the MOM is not enough to complete the intervention as assigned

Intervention group: Feeds will be initiated with a target volume of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.

Control group: This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Preterm neonate with gestational age of 27-32 weeks

Exclusion criteria

  • Antenatally diagnosed GI malformation
  • Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.
  • Presence of major congenital anomalies at birth
  • Need of vasopressor support at the time of randomization
  • Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute

Treatment and study plan

Early Total Enteral Feeding

Other

This group will receive enteral feeding volumes at a rate of 80 ml/kg/day starting within the first two hours after birth. Volumes will increased by 20 ml/kg/day till day 4 (total 140 ml/kg/d) and then 150ml/kg/day on day 5.

Conventional Enteral Feeding

Other

This group will receive enteral feeding volumes at a rate of 20 ml/kg/day starting within the first two hours after birth and rest of the daily requirement as Total parenteral nutrition. Volumes will be increased by 20 ml/kg/day till day 3 and thereafter by 30 ml/kg/d till 150ml/kg/day on day 6.

Primary outcomes

  1. Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth

    Time frame: Birth to 28 days

    Days to attain full feeds during the first 28 days after birth

Secondary outcomes

  1. Number of episodes of feeding intolerance

    Time frame: From Randomization till 28 days after birth

    Feed intolerance will be defined as any one or more of the following a) Vomiting 3 or more in any 24 hour period, b) Any episode of blood stained or bilious vomiting, c) Abdominal girth(AG) increase >2 cm (with pre-feed aspirate >25%), abdominal wall erythema or tenderness, gross or occult blood in stools

  2. Incidence of Necrotising Enterocolitis

    Time frame: From Randomization till 28 days after birth

    Diagnosis of necrotizing enterocolitis any stage

  3. Incidence of Sepsis

    Time frame: From randomization till 28 days after birth

    Sepsis will be defined as any one of the following in a symptomatic neonate a) Culture positive sepsis b) Sepsis screen positive, c) Strong clinical suspicion such as sclerema, shock or clinical deterioration on supportive therapy which warrants initiation of antibiotics (clinician decision)

  4. Total duration of intravenous fluid usage

    Time frame: From randomization till 28 days after birth

    Duration in completed days for which infant required parenteral fluid support

  5. Time of regaining birth weight

    Time frame: From randomization till 28 days after birth

    Duration in completed days required to regain birth weight

  6. Total duration of hospital stay

    Time frame: From randomization till 2 months after birth

    Duration in completed days required for treatment till discharge home or till death

  7. Weight gain per kg per day at 1 month of age

    Time frame: Birth to 30 days

    The weight in grams at one month of age minus the birth weight divided by the average weight (average weight =birth weight +Weight at 1 month age divided by 2) further divided by 30

  8. Extrauterine growth retardation (EUGR)

    Time frame: Till 36 weeks Postmenstrual age

    Weight of the infants at 36 weeks Postmenstrual age or at discharge (if earlier) below the 10th centile for age

Sponsors and collaborators

Lead sponsor

Lady Hardinge Medical College

Other Gov

Registry information

Official study title

Early Total Enteral Feeding Versus Convention Enteral Feeding in Preterm Neonates Between 27 to 32 Weeks of Gestation: A Randomized Control Trial

Acronym: ETEFVsCEF

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2023
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.