Early Exclusive Enteral Nutrition in Early Preterm Infants

NCT ID: NCT03708068

Last Updated: 2024-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-16
• Study Completion Date: 2024-01-30

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.

Detailed Description

Early nutritional support of preterm infants born at 30-33 weeks gestation is usually achieved via a combination of parenteral nutrition (PN) and enteral feeding that is advanced over few days to reach full enteral feed. Recent studies suggest that rapid increase of enteral feed volumes results in shorter duration on PN and earlier achievement of full enteral feed without increasing the risk of necrotizing enterocolitis (NEC) or death. Although PN has an important role in nutrition of preterm infants, it is associated with increased risk of metabolic and infectious complications even when it is used for a short period of time. Furthermore, PN mandates the need for peripheral or central intravenous access. Provision of full enteral feed volume that meets reference daily fluid intake from day of birth is used frequently and successfully in stable preterm infants born after 33 weeks. Expanding the use of this regimen to stable preterm infants born at 30-33 weeks gestation may help avoid unnecessary start of intravenous access, prevent complications related to PN, and encourage mother-infant bonding experience.

Conditions

Enteral Nutrition

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Early Exclusive Enteral Nutrition

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.

Group Type: EXPERIMENTAL

Early exclusive enteral nutrition

Intervention Type: 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.

Conventional Enteral Nutrition

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Early exclusive enteral nutrition

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.

Intervention Type: OTHER

Other Intervention Names

Early Total Enteral Feed

Eligibility Criteria

Inclusion Criteria

1. Preterm infants born at 30 0/7 - 33 6/7 weeks gestation

2. Birth weight greater than 1000 g

3. Consent to use donor human milk

4. Postnatal age is less than 48 hours from birth

5. 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).

Exclusion Criteria

1. Cord PH < 7.00 or Cord base access (BE) < -16

2. Apgar score < 7 at 5 minute

3. Lactate level ≥3 (if done for clinical indication)

4. Need for positive pressure ventilation (PPV) for >1 minute.

5. Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours)

6. Small for gestational age <3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow.

7. Major congenital malformation

8. Symptomatic or severe hypoglycemia (blood glucose <1.8 mmol/L)

9. Infants with moderate to severe respiratory distress.

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Belal Alshaikh

OTHER

Sponsor Role: lead

Responsible Party

Belal Alshaikh

Neonatologist

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Belal Alshaikh, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Peter Lougheed Hospital

Calgary, Alberta, Canada

Foothills Medical Centre

Calgary, Alberta, Canada

South Health Campus

Calgary, Alberta, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 39894877 (View on PubMed)

Other Identifiers

REB18-0772

Identifier Type: -

Identifier Source: org_study_id