Early Exclusive Enteral Nutrition in Early Preterm Infants

Phase

N/A

Condition

Diet And Nutrition

Treatment

Early exclusive enteral nutrition

Clinical Study ID

NCT03708068

REB18-0772

Ages < 48
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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, whenalready started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feedsbased on current feeding policy or physician descrition (total volume of the receivedfeeds is ≤20 ml/kg per day).

Exclusion

Exclusion Criteria:

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 orreversed 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.

Study Design

Early exclusive enteral nutrition

April 16, 2019

January 30, 2024

Study 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.

Connect with a study center

Foothills Medical Centre
Calgary, Alberta T2N2T9
Canada
Site Not Available
Peter Lougheed Hospital
Calgary, Alberta T1Y6J4
Canada
Site Not Available
South Health Campus
Calgary, Alberta T3M1P9
Canada
Site Not Available

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