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NCT Number: NCT02998489

Effectiveness and Safety of Fast Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight

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)

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Key information

Conditions

Feeding Behavior Behavior Behavior, Animal Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 72 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fast milk advancement

Other

30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved

Other names: Milk

Traditional milk advancement

Other

20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved

Other names: Milk

Primary outcomes

  1. days to reach full enteral nutrition

    Time frame: 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

    number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.

  2. days of intravenous fluids

    Time frame: number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks

    number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes

Secondary outcomes

  1. days to regain birth weight

    Time frame: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks

    number of days employed to regain birth weight

  2. episodes of food intolerance

    Time frame: 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

    number of episodes of food intolerance per day during hospitalization

  3. weight at 40 weeks

    Time frame: weight at 40 weeks of post menstrual age

    weight in grams at 40 weeks of post menstrual age

  4. length at 40 weeks

    Time frame: length at 40 weeks of post menstrual age

    length in centimeters at 40 weeks of post menstrual age

  5. head circumference at 40 weeks

    Time frame: head circumference at 40 weeks of post menstrual age

    head circumference in centimeters at 40 weeks of post menstrual age

  6. weight gain per day at 40 weeks of post menstrual age

    Time frame: weight gain in grams per day from birth until 40 weeks of post menstrual age

    weight gain in gr./d from birth until 40 weeks of post menstrual age

  7. rate of necrotizing enterocolitis

    Time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)

    rate of necrotizing enterocolitis through study completion

  8. rate of mortality

    Time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)

    number of patients who died during the study's follow up

  9. rate of late onset sepsis

    Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks

    number of patients who had late onset sepsis during hospitalization

  10. rate of hyperbilirubinemia

    Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks

    number of patients who had hyperbilirubinemia and were treated with phototherapy during hospitalization

  11. rate of hypoglycemia

    Time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks

    number of patients who had hypoglycemia during hospitalization

Sponsors and collaborators

Lead sponsor

Hospital Universitario San Ignacio

Other

Registry information

Official study title

Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 20, 2016
Registry last updated
Mar 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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