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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03708068
Other study ID # REB18-0772
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 16, 2019
Est. completion date January 30, 2024

Study information

Verified date April 2024
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date January 30, 2024
Est. primary completion date October 24, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 48 Hours
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.

Locations

Country Name City State
Canada Foothills Medical Centre Calgary Alberta
Canada Peter Lougheed Hospital Calgary Alberta
Canada South Health Campus Calgary Alberta

Sponsors (1)

Lead Sponsor Collaborator
Belal Alshaikh

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Length of hospital stay Length of hospital stay in days At discharge from neonatal intensive care unit (NICU), up to 90 days of life
Secondary Feeding intolerance Presence of one or more of the following:
vomiting more than 2 times during any 24 h period,
any episode of bile- or blood-stained vomiting,
abdominal wall erythema or tenderness that resulted in cessation of feed.
Till 30 days of life
Secondary Incidence of late onset sepsis Any microbial growth in blood, cerebrospinal fluid or urine after 72 hours of admission in NICU At discharge from NICU, up to 90 days of life
Secondary Incidence of NEC Any Stage II and above according to Bell's staging criteria At discharge from NICU, up to 90 days of life
Secondary Incidence of hypoglycemia Defined as point of care testing Glucose < 2.6 mmol/L at any time after rollment in study Till 30 days of life
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