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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher Volume Feeding Goal | Active Comparator | Infants randomized to this group will have higher volume feeding goals of 180-200 ml/kg/day. |
|
| Usual Volume Feeding Goal | No Intervention | Infants randomized to this group will have feeding goals of 140-160 ml/kg/day. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher Volume Feeding Goal | Other | feeding volume goal of 180-200 ml/kg/day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weight gain | Average change in weight between baseline and 12 weeks | baseline to average 12 weeks of age |
| 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 |
| 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) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Waldemar A Carlo, MD | University of Alabama at Birmingham | Study Director |
| Colm Travers, MD | University of Alabama at Birmingham | Principal Investigator |
| Ariel A Salas, MD | University of Alabama at Birmingham |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33248115 | Derived | 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. | |
| 32464224 | Derived | 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. |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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 |
| 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 |
| D000091642 | Urogenital Diseases |