Enteral NutritionNCT03708068
Early Exclusive Enteral Nutrition in Early Preterm Infants
A study testing Early exclusive enteral nutrition in people with Enteral Nutrition, run by Belal Alshaikh at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Enteral Nutrition
- What is being tested?
- Early exclusive enteral nutrition
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 3 sitesCanada
- Study dates
- 16 Apr 2019to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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.
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- Major congenital malformation
- Symptomatic or severe hypoglycemia (blood glucose <1.8 mmol/L)
- Infants with moderate to severe respiratory distress.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Peter Lougheed Hospital
Calgary, Alberta, T1Y6J4
Foothills Medical Centre
Calgary, Alberta, T2N2T9
South Health Campus
Calgary, Alberta, T3M1P9
About this study
Official title: 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.
Read the 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
- Being tested
- Early exclusive enteral nutrition
- Keywords
- Exclusive, Enteral Nutrition, Preterm Infant
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early exclusive enteral nutritionOther
Also called Early Total 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.
| Study group | Role | What they receive |
|---|---|---|
| Early Exclusive Enteral Nutrition | Experimental | 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. Receives: Other: Early exclusive enteral nutrition |
| Conventional Enteral Nutrition | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Till 30 days of life
Secondary outcomes (5)
Length of hospital stay
Length of hospital stay in days
Measured: At discharge from neonatal intensive care unit (NICU), up to 90 days of life
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.
Measured: Till 30 days of life
Incidence of late onset sepsis
Any microbial growth in blood, cerebrospinal fluid or urine after 72 hours of admission in NICU
Measured: At discharge from NICU, up to 90 days of life
Incidence of NEC
Any Stage II and above according to Bell's staging criteria
Measured: At discharge from NICU, up to 90 days of life
Incidence of hypoglycemia
Defined as point of care testing Glucose < 2.6 mmol/L at any time after rollment in study
Measured: Till 30 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start16 Apr 2019
- Primary completion24 Oct 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enteral NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belal Alshaikh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Belal Alshaikh, University of Calgary
- Investigators
- Belal Alshaikh, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03708068
- Sponsor's protocol ID
- REB18-0772
- Status last verified
- Apr 2024
- First submitted
- 1 Oct 2018
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39894877
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Exclusive Enteral Nutrition in Stable Preterm Infants at 30 0/7 - 33 6/7 Weeks Gestation: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03708068
- Acronym / sponsor ID
- REB18-0772
- Conditions
- Enteral Nutrition
- Keywords
- Exclusive, Enteral Nutrition, Preterm Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Belal AlshaikhUniversity, hospital or other
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 24 Oct 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Exclusive Enteral Nutrition | Experimental | Other: Early exclusive enteral nutritionFeeds 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. |
| Conventional Enteral Nutrition | No intervention | –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. |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early exclusive enteral nutritionAlso: Early Total Enteral FeedInfants 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 | Early Exclusive Enteral Nutrition |
Primary outcome
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
5 secondary outcomes
Length of hospital stay
Time frame: At discharge from neonatal intensive care unit (NICU), up to 90 days of life
Feeding intolerance
Time frame: Till 30 days of life
Incidence of late onset sepsis
Time frame: 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
Incidence of hypoglycemia
Time frame: Till 30 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Derived from this study: PubMed 39894877Alshaikh 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Belal Alshaikh, MD principal investigator
University of Calgary
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early exclusive enteral nutrition in people with Enteral Nutrition, run by Belal Alshaikh at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration to achieve of full enteral feeds in days (time frame: Till 30 days of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03708068, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.