Early Versus Delayed Feeding in Preterm Growth-Restricted Infants

Early Versus Delayed Enteral Feeding for Achieving Full Feeding in Preterm Growth-Restricted Infants: A Randomized Clinical Trial

The introduction of enteral feeds for preterm, growth restricted infants are often delayed due to concern that early introduction may not be tolerated and may increase the risk of necrotizing enterocolitis. However, prolonged enteral fasting may diminish the functional adaptation of the immature gastrointestinal tract and extend the need for parenteral nutrition with its attendant infectious and metabolic risks. Early introduction of small volumes of milk in the form of Trophic feeding, promote intestinal maturation, may enhance feeding tolerance and decrease the time taken to reach full enteral feeding independently of parenteral nutrition.

A Randomized Trial will be carried out over a period of 12 months in Department of Neonatology of BSMMU. Sample size will be 50(25 in each group). Infants with gestation below 35 weeks, birth weight below the 10th percentile for gestational age, will be randomly allocated by web-based randomization to commence enteral feeds "early," whose feeding will be started from 24 to 48 hours of age or "late," whose feeding will be started from 48 to 72 hours of age. Gradually feeding will be increased. Rate of advancement of feeding will be same for both groups. Primary outcomes will be time to achieve full enteral feeding sustained for 72 hours. Statistical analyses will be performed by using Fisher Exact test and by Student's t test for categorical data and quantitative data respectively. Logistic regression analyses will be performed to determine the role of independent variable.

Study Overview

• Status: Unknown
• Conditions: Preterm Infant; IUGR
• Intervention / Treatment: Other: breast milk

Detailed Description

Eligible infants who will fulfill the inclusion criteria will be divided into two strata "Early feeding group" and " Late feeding group" by computer based randomization after taking informed written consent from parents or responsible caregivers. Feeding will be started in early feeding group from 24 to 48 hours of age or in late feeding group, from 48 to 72 hours of age. Initially 4 hourly feeding will be started with 0.5ml and 1 ml expressed breast milk in babies with birth weight <1200 grams and >1200 grams respectively. On the following day 3 hourly, thereafter 2 hourly feeding will be provided in both groups. Gradually amount of feeding will be increased after reaching 2 hourly feeding at the rate of 10 ml/kg/day for initial 10 days then 20ml/kg/day in 2 aliquots till full feeding(150ml/kg/day).For babies with birth weight <1200 gram, rate of feeding advancement 10 ml/kg/day till full feeds. Any baby who will develop shock (due to sepsis, cardiogenic, hypovolemic etc.) will be excluded and will be replaced by new one in same category as per protocol analysis. Follow up examinations will be done.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All growth restricted preterm Infants of both sexes with gestational age 35 weeks or less and birth weight below 10th percentile for gestational age

Exclusion Criteria:

• • Hemodynamically unstable critically ill neonates.

  • Newborn with severe perinatal asphyxia.
  • Newborn with polycythemia requiring exchange transfusion
  • Newborn with major congenital anomalies
  • Syndromic manifestations or chromosomal malformations
  • Suspected inborn errors of metabolism.
  • Any baby who will have proven sepsis with shock or necrotizing enterocolitis will be excluded and will be replaced by new one in same category as per protocol analysis.
  • Any baby who develop shock (due to sepsis, cardiogenic, hypovolemic etc.) will be excluded and will be replaced by new one in same category as per protocol analysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early Feeding group; Active ingredient: maternal expressed breast milk Time of initiation of first feeding: 24 to 48 hours of age. Doses: Initially 4 hourly feeding will be started with 0.5 ml and 1 ml expressed breast milk in babies with birth weight <1200 grams and >1200 grams respectively. On the following day 3 hourly, thereafter 2 hourly feeding will be provided in both groups. Gradually amount of feeding will be increased after reaching 2 hourly feeding at the rate of 10 ml/kg/day for initial 10 days then 20ml/kg/day in 2 aliquots till full feeding(150ml/kg/day).For babies with birth weight <1200 gram, rate of feeding advancement 10 ml/kg/day till full feeds. Time of starting first feeding and time to reach full feeding, both will be documented in a questionnaire for each patient.	Other: breast milk; Feeding with breast milk will be started in early feeding group from 24 to 48 hours of age or in late feeding group, from 48 to 72 hours of age. Initially 4 hourly feeding will be started with 0.5ml and 1 ml expressed breast milk in babies with birth weight <1200 grams and >1200 grams respectively. gradually volume of milk should be increased
NO_INTERVENTION: Late Feeding group; Feeding with maternal breast milk will be given in conventional way

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of feeding with weight gain pattern	Early achievement of acceptable weight gain 20-25 gram per day	1 year

Collaborators and Investigators

• Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2018
• Study Completion (ANTICIPATED): December 31, 2018

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 16, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 16, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: U1111-1203-7088

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No