- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03708068
Early Exclusive Enteral Nutrition in Early Preterm Infants
April 19, 2024 updated by: Belal Alshaikh
Early Exclusive Enteral Nutrition in Stable Preterm Infants at 30 0/7 - 33 6/7 Weeks Gestation: A Randomized Controlled Trial
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Belal Alshaikh, MD
- Phone Number: 403-956-1588
- Email: balshaik@ucalgary.ca
Study Locations
-
-
Alberta
-
Calgary, Alberta, Canada, T2N2T9
- Foothills Medical Centre
-
Calgary, Alberta, Canada, T1Y6J4
- Peter Lougheed Hospital
-
Calgary, Alberta, Canada, T3M1P9
- South Health Campus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 1 year (Child)
Accepts Healthy Volunteers
No
Description
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, 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:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
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.
Other Names:
|
No Intervention: Conventional Enteral Nutrition
Infants will be fed as per current Neonatal Intensive Care Unit feeding tables:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration to achieve of full enteral feeds in days
Time Frame: Till 30 days of life
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of hospital stay
Time Frame: At discharge from neonatal intensive care unit (NICU), up to 90 days of life
|
Length of hospital stay in days
|
At discharge from neonatal intensive care unit (NICU), up to 90 days of life
|
Feeding intolerance
Time Frame: Till 30 days of life
|
Presence of one or more of the following:
|
Till 30 days of life
|
Incidence of late onset sepsis
Time Frame: At discharge from NICU, up to 90 days of life
|
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
|
Incidence of NEC
Time Frame: At discharge from NICU, up to 90 days of life
|
Any Stage II and above according to Bell's staging criteria
|
At discharge from NICU, up to 90 days of life
|
Incidence of hypoglycemia
Time Frame: Till 30 days of life
|
Defined as point of care testing Glucose < 2.6 mmol/L at any time after rollment in study
|
Till 30 days of life
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Belal Alshaikh, MD, University of Calgary
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 16, 2019
Primary Completion (Actual)
October 24, 2023
Study Completion (Actual)
January 30, 2024
Study Registration Dates
First Submitted
October 1, 2018
First Submitted That Met QC Criteria
October 11, 2018
First Posted (Actual)
October 16, 2018
Study Record Updates
Last Update Posted (Actual)
April 22, 2024
Last Update Submitted That Met QC Criteria
April 19, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REB18-0772
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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