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What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Enteral Nutrition

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Early exclusive enteral nutritionInfants 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 Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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 NutritionInfants will be fed as per current Neonatal Intensive Care Unit feeding tables: 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. 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.

Study Status

Not yet recruiting

Start Date: November 2018

Completed Date: December 2020

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Duration to achieve of full enteral feeds in days

Secondary Outcome: Length of hospital stay

Study sponsors, principal investigator, and references

Principal Investigator: Belal Alshaikh, MD

Lead Sponsor: Belal Alshaikh

Collaborator:

More information:https://clinicaltrials.gov/show/NCT03708068