Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

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

Study Overview

• Status: Completed
• Conditions: Infant Premature
• Intervention / Treatment: Other: Higher Volume Feeding Goal

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.

• Study Type: Interventional
• Enrollment (Actual): 224
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 1 month (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body fat composition	Percentage of body fat composition	36 weeks or discharge
Rates of necrotizing enterocolitis (Bell Stage ≥ 2)	Safety outcome: Rates of necrotizing enterocolitis (Bell Stage ≥ 2)	36 weeks or discharge
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
Rates of culture proven sepsis	Safety outcome: Rates of blood culture positive sepsis after study entry	36 weeks or discharge
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
Rates of bronchopulmonary dysplasia	Safety outcome: Rates of bronchopulmonary dysplasia	36 weeks or discharge
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
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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Colm Travers, MD, University of Alabama at Birmingham; Ariel A Salas, MD, University of Alabama at Birmingham

Publications and helpful links

General Publications

• Salas AA, Travers CP, Jerome ML, Chandler-Laney P, Carlo WA. Percent Body Fat Content Measured by Plethysmography in Infants Randomized to High- or Usual-Volume Feeding after Very Preterm Birth. J Pediatr. 2021 Mar;230:251-254.e3. doi: 10.1016/j.jpeds.2020.11.028. Epub 2020 Nov 25.
• Travers CP, Wang T, Salas AA, Schofield E, Dills M, Laney D, Yee A, Bhatia A, Winter L, Ambalavanan N, Carlo WA. Higher- or Usual-Volume Feedings in Infants Born Very Preterm: A Randomized Clinical Trial. J Pediatr. 2020 Sep;224:66-71.e1. doi: 10.1016/j.jpeds.2020.05.033. Epub 2020 May 25.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): June 1, 2018

Study Registration Dates

• First Submitted: December 1, 2014
• First Submitted That Met QC Criteria: February 24, 2015
• First Posted (Estimate): March 3, 2015

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 14, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Nutritional support
• Other Study ID Numbers: UAB NEO 013