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

Enteral Feeding Intolerance Clinical Trial

— ETEFVsCEF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06076460
• Other study ID #: LHMC/IEC/2021/03/68
• Status: Recruiting
• Phase: N/A
• Start date: March 11, 2022
• Est. completion date: March 10, 2024

Study information

• Verified date: October 2023
• Source: Lady Hardinge Medical College
• Contact: Sushma Nangia, DM (Neo)
• Phone: 9810838181
• Email: drsnangia[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: March 10, 2024
• Est. primary completion date: January 10, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 1 Hour

Eligibility

Inclusion Criteria:

Preterm neonate with gestational age of 27-32 weeks

Exclusion Criteria:

1. Antenatally diagnosed GI malformation

2. Baby born with absence or reversal of end diastolic flow on antenatal umbilical artery Doppler.

3. Presence of major congenital anomalies at birth

4. Need of vasopressor support at the time of randomization

5. Requiring Positive Pressure Ventilation > 60 sec with APGAR score < 4 at 1 minute

Related Conditions & MeSH terms

• Enteral Feeding Intolerance
• Premature Birth
• Very Preterm Maturity of Infant

Intervention

Other:
• Early Total Enteral Feeding
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
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.

Locations

Country	Name	City	State
India	Lady Hardinge Medical College	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Lady Hardinge Medical College

Country where clinical trial is conducted

India, 

References & Publications (2)

Nangia S, Bishnoi A, Goel A, Mandal P, Tiwari S, Saili A. Early Total Enteral Feeding in Stable Very Low Birth Weight Infants: A Before and After Study. J Trop Pediatr. 2018 Feb 1;64(1):24-30. doi: 10.1093/tropej/fmx023. — View Citation

Walsh V, Brown JVE, Copperthwaite BR, Oddie SJ, McGuire W. Early full enteral feeding for preterm or low birth weight infants. Cochrane Database Syst Rev. 2020 Dec 27;12(12):CD013542. doi: 10.1002/14651858.CD013542.pub2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of attainment of full enteral feeds (150ml/kg/day) during the first 28 days after birth	Days to attain full feeds during the first 28 days after birth	Birth to 28 days
Secondary	Number of episodes of feeding intolerance	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	From Randomization till 28 days after birth
Secondary	Incidence of Necrotising Enterocolitis	Diagnosis of necrotizing enterocolitis any stage	From Randomization till 28 days after birth
Secondary	Incidence of Sepsis	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)	From randomization till 28 days after birth
Secondary	Total duration of intravenous fluid usage	Duration in completed days for which infant required parenteral fluid support	From randomization till 28 days after birth
Secondary	Time of regaining birth weight	Duration in completed days required to regain birth weight	From randomization till 28 days after birth
Secondary	Total duration of hospital stay	Duration in completed days required for treatment till discharge home or till death	From randomization till 2 months after birth
Secondary	Weight gain per kg per day at 1 month of age	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	Birth to 30 days
Secondary	Extrauterine growth retardation (EUGR)	Weight of the infants at 36 weeks Postmenstrual age or at discharge (if earlier) below the 10th centile for age	Till 36 weeks Postmenstrual age