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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Conventional Enteral Nutrition | No Intervention | Infants will be fed as per current Neonatal Intensive Care Unit feeding tables:
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early exclusive enteral nutrition | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Length of hospital stay in days | At discharge from neonatal intensive care unit (NICU), up to 90 days of life |
| Feeding intolerance | Presence of one or more of the following:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Belal Alshaikh, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peter Lougheed Hospital | Calgary | Alberta | T1Y6J4 | Canada | ||
| Foothills Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39894877 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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|
| 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 | At discharge from NICU, up to 90 days of life |
| Incidence of NEC | Any Stage II and above according to Bell's staging criteria | 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 | Till 30 days of life |
| Calgary |
| Alberta |
| T2N2T9 |
| Canada |
| South Health Campus | Calgary | Alberta | T3M1P9 | Canada |
| D000091642 | Urogenital Diseases |