Clinical trial NCT03708068: Early Exclusive Enteral Nutrition in Early Preterm Infants
Official title: Early Exclusive Enteral Nutrition in Stable Preterm Infants at 30 0/7 - 33 6/7 Weeks Gestation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enteral Nutrition
Keywords: Exclusive
Enteral Nutrition
Preterm Infant
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 69
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Duration to achieve of full enteral feeds in days
timeFrame: Till 30 days of life
Secondary outcomes:
measure: Length of hospital stay
timeFrame: At discharge from neonatal intensive care unit (NICU), up to 90 days of life
measure: Feeding intolerance
timeFrame: Till 30 days of life
measure: Incidence of late onset sepsis
timeFrame: At discharge from NICU, up to 90 days of life
measure: Incidence of NEC
timeFrame: At discharge from NICU, up to 90 days of life
measure: Incidence of hypoglycemia
timeFrame: Till 30 days of life
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Peter Lougheed Hospital
state: Alberta
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Calgary
country: Canada
facility: South Health Campus
state: Alberta
Study officials:
affiliation: University of Calgary
name: Belal Alshaikh, MD
role: PRINCIPAL_INVESTIGATOR
References: