Clinical trial NCT02377050: Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Official title: Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Premature
Keywords: Nutritional support
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 224
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight gain
timeFrame: baseline to average 12 weeks of age
Secondary outcomes:
measure: Mid arm circumference
timeFrame: baseline to average 12 weeks of age
measure: Length
timeFrame: baseline to average 12 weeks of age
measure: Head circumference
timeFrame: baseline to average 12 weeks of age
measure: Caloric intake
timeFrame: 36 weeks
measure: Length of stay
timeFrame: 36 weeks or discharge
measure: Rates of infants less than 10th percentile for weight
timeFrame: 36 weeks or discharge
measure: Change in weight z score
timeFrame: 36 weeks or discharge
measure: Change in length z score
timeFrame: 36 weeks or discharge
measure: Change in head circumference z score
timeFrame: 36 weeks or discharge
Other outcomes:
measure: Body fat composition
timeFrame: 36 weeks or discharge
measure: Rates of necrotizing enterocolitis (Bell Stage ≥ 2)
timeFrame: 36 weeks or discharge
measure: Rates of feeding intolerance
timeFrame: 36 weeks or discharge
measure: Rates of culture proven sepsis
timeFrame: 36 weeks or discharge
measure: Duration of respiratory support
timeFrame: 36 weeks or discharge
measure: Rates of bronchopulmonary dysplasia
timeFrame: 36 weeks or discharge
measure: Rates of moderate to large or symptomatic patent ductus arteriosus
timeFrame: 36 weeks or discharge
measure: Rates of adverse safety outcomes combined
timeFrame: 36 weeks or discharge
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar A Carlo, MD
role: STUDY_DIRECTOR
affiliation: University of Alabama at Birmingham
name: Colm Travers, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Ariel A Salas, MD
References:
citation: 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.
citation: 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.