Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

Infant Premature Clinical Trial

Official title:

Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02377050
• Other study ID #: UAB NEO 013
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

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

Related Conditions & MeSH terms

• Infant Premature

Intervention

Other:
• Higher Volume Feeding Goal
feeding volume goal of 180-200 ml/kg/day

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body fat composition	Percentage of body fat composition	36 weeks or discharge
Other	Rates of necrotizing enterocolitis (Bell Stage = 2)	Safety outcome: Rates of necrotizing enterocolitis (Bell Stage = 2)	36 weeks or discharge
Other	Rates of feeding intolerance	Safety outcome: Rates of feeding intolerance defined as withholding feeds for > 24 hours due to gastrointestinal cause after study entry	36 weeks or discharge
Other	Rates of culture proven sepsis	Safety outcome: Rates of blood culture positive sepsis after study entry	36 weeks or discharge
Other	Duration of respiratory support	Safety outcome: Duration of respiratory support (oxygen, continuous positive airway pressure/high flow nasal cannula/mechanical ventilation) after study entry	36 weeks or discharge
Other	Rates of bronchopulmonary dysplasia	Safety outcome: Rates of bronchopulmonary dysplasia	36 weeks or discharge
Other	Rates of moderate to large or symptomatic patent ductus arteriosus	Safety outcome: Rates of moderate to large or symptomatic patent ductus arteriosus after study entry	36 weeks or discharge
Other	Rates of adverse safety outcomes combined	Safety outcome: Safety outcome: Rates of bronchopulmonary dysplasia, necrotizing enterocolitis = stage 2, feeding intolerance, culture proven sepsis, patent ductus arteriosus after study entry	36 weeks or discharge
Primary	Weight gain	Average change in weight between baseline and 12 weeks	baseline to average 12 weeks of age
Secondary	Mid arm circumference	average change in mid arm circumference between baseline and 12 weeks	baseline to average 12 weeks of age
Secondary	Length	average change in length between baseline and 12 weeks	baseline to average 12 weeks of age
Secondary	Head circumference	average change in head circumference between baseline and 12 weeks	baseline to average 12 weeks of age
Secondary	Caloric intake	Average difference in weekly caloric intake between groups	36 weeks
Secondary	Length of stay	Days from study entry to discharge home	36 weeks or discharge
Secondary	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
Secondary	Change in weight z score	Change in weight z score from study entry to completion	36 weeks or discharge
Secondary	Change in length z score	Change in length z score from study entry to completion	36 weeks or discharge
Secondary	Change in head circumference z score	Change in head circumference z score from study entry to completion	36 weeks or discharge