Infant Premature
Conditions
Keywords
Nutritional support
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.
Interventions
OTHERHigher Volume Feeding Goal
feeding volume goal of 180-200 ml/kg/day
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight gain | baseline to average 12 weeks of age | Average change in weight between baseline and 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length | baseline to average 12 weeks of age | average change in length between baseline and 12 weeks |
| Mid arm circumference | baseline to average 12 weeks of age | average change in mid arm circumference between baseline and 12 weeks |
| Head circumference | baseline to average 12 weeks of age | average change in head circumference between baseline and 12 weeks |
| Caloric intake | 36 weeks | Average difference in weekly caloric intake between groups |
| Length of stay | 36 weeks or discharge | Days from study entry to discharge home |
| Rates of infants less than 10th percentile for weight | 36 weeks or discharge | Rates of infants less than 10th percentile for weight at study completion |
| Change in weight z score | 36 weeks or discharge | Change in weight z score from study entry to completion |
| Change in length z score | 36 weeks or discharge | Change in length z score from study entry to completion |
| Change in head circumference z score | 36 weeks or discharge | Change in head circumference z score from study entry to completion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of feeding intolerance | 36 weeks or discharge | Safety outcome: Rates of feeding intolerance defined as withholding feeds for \> 24 hours due to gastrointestinal cause after study entry |
| Rates of culture proven sepsis | 36 weeks or discharge | Safety outcome: Rates of blood culture positive sepsis after study entry |
| Duration of respiratory support | 36 weeks or discharge | Safety outcome: Duration of respiratory support (oxygen, continuous positive airway pressure/high flow nasal cannula/mechanical ventilation) after study entry |
| Rates of bronchopulmonary dysplasia | 36 weeks or discharge | Safety outcome: Rates of bronchopulmonary dysplasia |
| Rates of moderate to large or symptomatic patent ductus arteriosus | 36 weeks or discharge | Safety outcome: Rates of moderate to large or symptomatic patent ductus arteriosus after study entry |
| Rates of adverse safety outcomes combined | 36 weeks or discharge | Safety outcome: Safety outcome: Rates of bronchopulmonary dysplasia, necrotizing enterocolitis ≥ stage 2, feeding intolerance, culture proven sepsis, patent ductus arteriosus after study entry |
| Rates of necrotizing enterocolitis (Bell Stage ≥ 2) | 36 weeks or discharge | Safety outcome: Rates of necrotizing enterocolitis (Bell Stage ≥ 2) |
| Body fat composition | 36 weeks or discharge | Percentage of body fat composition |
Countries
United States
Outcome results
None listed