Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

Conditions
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Infant Premature

Intervention / Treatment
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* Other: Higher Volume Feeding Goal


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higher Volume Feeding Goal<br>Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day. | Other: Higher Volume Feeding Goal<br>* feeding volume goal of 180-200 ml/kg/day<br>|
| No Intervention: Usual Volume Feeding Goal<br>Infants randomized to this group will have feeding goals of 140-160 ml/kg/day. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain | Average change in weight between baseline and 12 weeks | baseline to average 12 weeks of age | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nutritional support