Early Exclusive Enteral Nutrition in Early Preterm Infants

NCT03708068 | Completed DMC

• 1 other identifier: REB18-0772
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 3

Brief Summary

Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and prevent excessive weight loss and dehydration. Availability of donor human milk (DHM) along with low incidence of necrotizing enterocolitis (NEC) in preterm infants born at 30-33 weeks have encouraged neonatologists to start feeding early and advance it faster in order to shorten time on parenteral nutrition (PN) and minimize the need for intravenous access. The objectives of this trial is to study whether exclusive enteral nutrition from day of birth (i.e. no PN) results in shorter time to achieve full enteral feed when compared with traditional feeding regimen that involves a combination of PN and progressive enteral feeding.

Conditions

Enteral Nutrition

Keywords

Exclusive; Enteral Nutrition; Preterm Infant

Outcome Measures

Primary Outcomes (1)

• Duration to achieve of full enteral feeds in days

  Day of life to achieve full enteral feeding defined as 140 ml/kg/day which is sustained for at least 3 days

  Till 30 days of life

Secondary Outcomes (5)

• Length of hospital stay

  At discharge from neonatal intensive care unit (NICU), up to 90 days of life

• Feeding intolerance

  Till 30 days of life

• Incidence of late onset sepsis

  At discharge from NICU, up to 90 days of life

• Incidence of NEC

  At discharge from NICU, up to 90 days of life

• Incidence of hypoglycemia

  Till 30 days of life

Study Arms (2)

Early Exclusive Enteral Nutrition

EXPERIMENTAL

Feeds will start at least at 80% of reference daily fluid intake from day one of life. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feed.

Other: Early exclusive enteral nutrition

Conventional Enteral Nutrition

NO INTERVENTION

Infants will be fed as per current Neonatal Intensive Care Unit feeding tables: 1. Infants with birth weight 1000-1500 g will be fed on 15-20 ml/kg human milk in day one. Feeds will be advanced by 15-20 ml/kg per day on second day onwards until infant reaches full enteral feeds. 2. Infants with birth weight \>1500 g will be started on 20-30 ml/kg per day on day one. Feeds will be advanced by 20-30 ml/kg per day on second day onwards until infant reaches full enteral feeds.

Interventions

Early exclusive enteral nutrition OTHER

Infants will be fed at least 80% of reference daily fluid intake from day one. Feeds will be advanced by 20-30 ml/kg per day on second day onwards to meet reference daily fluid intake until infant reaches full enteral feed.

Also known as: Early Total Enteral Feed

Early Exclusive Enteral Nutrition

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
• Birth weight greater than 1000 g
• Consent to use donor human milk
• Postnatal age is less than 48 hours from birth
• Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day).

You may not qualify if:

• Cord PH \< 7.00 or Cord base access (BE) \< -16
• Apgar score \< 7 at 5 minute
• Lactate level ≥3 (if done for clinical indication)
• Need for positive pressure ventilation (PPV) for \>1 minute.
• Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours)
• Small for gestational age \<3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow.
• Major congenital malformation
• Symptomatic or severe hypoglycemia (blood glucose \<1.8 mmol/L)
• Infants with moderate to severe respiratory distress.

Sponsors & Collaborators

• Belal Alshaikh: lead

Study Sites (3)

Peter Lougheed Hospital

Calgary, Alberta, T1Y6J4, Canada

Location

Foothills Medical Centre

Calgary, Alberta, T2N2T9, Canada

Location

South Health Campus

Calgary, Alberta, T3M1P9, Canada

Location

Related Publications (1)

• Alshaikh BN, Hassan O, Alburaki W, Dharel D, Elsharkawy A, Singal N, Yusuf K, Awad EA. Early exclusive enteral feeding in 30-33 weeks gestation infants: a randomized controlled trial. J Perinatol. 2025 May;45(5):628-634. doi: 10.1038/s41372-025-02217-0. Epub 2025 Feb 2.

  PMID: 39894877 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Belal Alshaikh, MD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Neonatologist

Study Record Dates

• First Submitted: October 1, 2018
• First Posted: October 16, 2018
• Study Start: April 16, 2019
• Primary Completion: October 24, 2023
• Study Completion: January 30, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Locations

CA (3)