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

NCT02998489 | Completed DMC

• 1 other identifier: 2014/25
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Feeding Behavior

Keywords

enteral nutrition; infant,premature; feeding method

Outcome Measures

Primary Outcomes (2)

• days to reach full enteral nutrition

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

  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

• days of intravenous fluids

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

  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 (11)

• days to regain birth weight

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

• episodes of food intolerance

  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

• weight at 40 weeks

  weight at 40 weeks of post menstrual age

• length at 40 weeks

  length at 40 weeks of post menstrual age

• head circumference at 40 weeks

  head circumference at 40 weeks of post menstrual age

Study Arms (2)

Fast milk advancement

EXPERIMENTAL

30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction

Other: Fast milk advancement

Traditional milk advancement

ACTIVE COMPARATOR

20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction

Other: Traditional milk advancement

Interventions

Fast milk advancement OTHER

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

Also known as: Milk

Fast milk advancement

Traditional milk advancement OTHER

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

Also known as: Milk

Traditional milk advancement

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario San Ignacio: lead

Related Publications (2)

• 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.

  PMID: 26469124 RESULT

• Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.

  PMID: 21730906 RESULT

MeSH Terms

Conditions

Feeding Behavior; Premature Birth

Interventions

Milk

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Adriana Montealegre, Dr.

  Hospital Universitario San Ignacio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2016
• First Posted: December 20, 2016
• Study Start: April 1, 2014
• Primary Completion: December 31, 2015
• Study Completion: September 12, 2016
• Last Updated: March 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share