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

Feeding Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02998489
• Other study ID #: 2014/25
• Status: Completed
• Phase: N/A
• First received: December 11, 2016
• Last updated: March 22, 2018
• Start date: April 1, 2014
• Est. completion date: September 12, 2016

Study information

• Verified date: March 2018
• Source: Hospital Universitario San Ignacio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 12, 2016
• Est. primary completion date: December 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 72 Hours

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Feeding Behavior

Intervention

Other:
• Fast milk advancement
30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
• Traditional milk advancement
20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitario San Ignacio

References & Publications (2)

Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e. — View 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. Review. Update in: Co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	days to regain birth weight	number of days employed 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
Secondary	episodes of food intolerance	number of episodes of food intolerance per day during hospitalization	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
Secondary	weight at 40 weeks	weight in grams at 40 weeks of post menstrual age	weight at 40 weeks of post menstrual age
Secondary	length at 40 weeks	length in centimeters at 40 weeks of post menstrual age	length at 40 weeks of post menstrual age
Secondary	head circumference at 40 weeks	head circumference in centimeters at 40 weeks of post menstrual age	head circumference at 40 weeks of post menstrual age
Secondary	weight gain per day at 40 weeks of post menstrual age	weight gain in gr./d from birth until 40 weeks of post menstrual age	weight gain in grams per day from birth until 40 weeks of post menstrual age
Secondary	rate of necrotizing enterocolitis	rate of necrotizing enterocolitis through study completion	through study completion(from date of randomization until 40 weeks of post menstrual age)
Secondary	rate of mortality	number of patients who died during the study's follow up	through study completion(from date of randomization until 40 weeks of post menstrual age)
Secondary	rate of late onset sepsis	number of patients who had late onset sepsis during hospitalization	from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
Secondary	rate of hyperbilirubinemia	number of patients who had hyperbilirubinemia and were treated with phototherapy during hospitalization	from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
Secondary	rate of hypoglycemia	number of patients who had hypoglycemia during hospitalization	from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks