NCT02377050

Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 1 Day – 1 Month
• Healthy volunteers: Not accepted

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.

Conditions

• Infant Premature

Interventions

Type	Name	Description
OTHER	Higher Volume Feeding Goal	feeding volume goal of 180-200 ml/kg/day

Timeline

• Start date: 2015-01-01
• Primary completion: 2018-06-01
• Completion: 2018-06-01
• First posted: 2015-03-03
• Last updated: 2018-06-18

Locations

1 site across 1 country: United States