Clinical trial NCT02998489: Effectiveness and Safety of Fast Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
Official title: Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding Behavior
Keywords: enteral nutrition
infant,premature
feeding method
Lead sponsor: Hospital Universitario San Ignacio
Sponsor class: OTHER
First posted: 2016-12-20
Enrollment: 36
Sex: ALL
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a randomized controlled trial with infants less than 34 weeks and between 1000 and 2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)

Detailed description: Progression of enteral feeding in preterm infants is still controversial. The neonatologist needs to provide adequate caloric intake avoiding the risk of food intolerance and necrotizing enterocolitis.

Objective: To establish the safety and effectiveness of fast enteral advancement compared with traditional advancement.

Design: A randomized controlled clinical trial with infants less than 34 weeks and between 1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá, Colombia.

Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc versus 20 cc / kg / day advancing in infants between 1500 and 1999g.

Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance, anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis, hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test. Multiple linear regression will be performed.

Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to parents.

Eligibility criteria: Inclusion Criteria:

* Infants less than 34 weeks of gestational age.
* Weight at birth between 1000 and 2000 grams.
* Infants hospitalized in the newborn unit at Hospital Universitario San Ignacio in Bogotá, Colombia.

Exclusion Criteria:

* Perinatal Asphyxia
* Intrauterine Growth Restriction
* Diagnosis of Congenital Hearth Disease
* Severe Hypoxemia
* Major Congenital Malformations
* Metabolic Disease
* Intolerance to initiate oral feeding at the eligibility
* Patent Ductus with hemodynamic instability
* Early Onset Sepsis with hemodynamic instability
* Refusal of parents to participate in the study

Primary outcomes:
measure: days to reach full enteral nutrition
timeFrame: number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks
measure: days of intravenous fluids
timeFrame: number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks
Secondary outcomes:
measure: days to regain birth weight
timeFrame: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks
measure: episodes of food intolerance
timeFrame: number of episodes of food intolerance per day from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
measure: weight at 40 weeks
timeFrame: weight at 40 weeks of post menstrual age
measure: length at 40 weeks
timeFrame: length at 40 weeks of post menstrual age
measure: head circumference at 40 weeks
timeFrame: head circumference at 40 weeks of post menstrual age
measure: weight gain per day at 40 weeks of post menstrual age
timeFrame: weight gain in grams per day from birth until 40 weeks of post menstrual age
measure: rate of necrotizing enterocolitis
timeFrame: through study completion(from date of randomization until 40 weeks of post menstrual age)
measure: rate of mortality
timeFrame: through study completion(from date of randomization until 40 weeks of post menstrual age)
measure: rate of late onset sepsis
timeFrame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
measure: rate of hyperbilirubinemia
timeFrame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
measure: rate of hypoglycemia
timeFrame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario San Ignacio
name: Adriana Montealegre, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2015 Oct 15;(10):CD001241. doi: 10.1002/14651858.CD001241.pub6.
citation: Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.