Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

Not Applicable

Completed

• Conditions: Infant Premature
• Interventions: Other: Higher Volume Feeding Goal

• Registration Number: NCT02377050
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The primary hypothesis is that preterm infants who are less than or equal to 32 weeks gestation and weigh 1001-2500 grams at birth will have an increase in weight gain with a feeding goal of 180-200 ml/kg/day more than the commonly used feeding goal of 140-160 ml/kg/day

Detailed Description

The proposed trial is designed to test the primary hypothesis that in preterm infants weighing 1001-2500 grams at birth and who are less than or equal to 32 weeks gestation, feeding goals of 180-200 ml/kg/day will increase weight gain (g/k/day) from time of enrollment to discharge home or 36 weeks post-menstrual age (PMA)(whichever comes first) more than the commonly used feeding goal volume of 140-160 ml/kg/day (usual feeding goal). This is a pilot study to determine the safety of increased volumes of feedings as opposed to fortification of feedings.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-12-01
• Study Start: 2015-01
• Study First Submitted QC: 2015-02-24
• Study First Posted: 2015-03-03
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-14
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Inborn or outborn infants born at a gestational age of 32 weeks or less; Birthweight 1001-2500; Feeding volume of at least 120 ml/kg/day; Enrolled prior to 28 days of age and prior to exceeding 32 weeks

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Exclusion Criteria

• Hemodynamically significant patent ductus arteriosis; History of necrotizing enterocolitis Bell Stage II or greater; Known gastrointestinal or neurologic malformations; Prior or planned enrollment into the NICHD MILK Trial; Terminal illness or decision to withhold or limit support

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher Volume Feeding Goal	Higher Volume Feeding Goal	Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day.

Primary Outcome Measures

Name	Time	Method
Weight gain	baseline to average 12 weeks of age	Average change in weight between baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
Length	baseline to average 12 weeks of age	average change in length between baseline and 12 weeks
Caloric intake	36 weeks	Average difference in weekly caloric intake between groups
Change in weight z score	36 weeks or discharge	Change in weight z score from study entry to completion
Change in length z score	36 weeks or discharge	Change in length z score from study entry to completion
Head circumference	baseline to average 12 weeks of age	average change in head circumference between baseline and 12 weeks
Change in head circumference z score	36 weeks or discharge	Change in head circumference z score from study entry to completion
Mid arm circumference	baseline to average 12 weeks of age	average change in mid arm circumference between baseline and 12 weeks
Length of stay	36 weeks or discharge	Days from study entry to discharge home
Rates of infants less than 10th percentile for weight	36 weeks or discharge	Rates of infants less than 10th percentile for weight at study completion

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States