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Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02377050
Recruitment Status : Completed
First Posted : March 3, 2015
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Colm Travers, University of Alabama at Birmingham

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

Condition or disease Intervention/treatment Phase
Infant Premature Other: Higher Volume Feeding Goal Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Study Start Date : January 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 2018

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.



Primary Outcome Measures :
  1. Weight gain [ Time Frame: baseline to average 12 weeks of age ]
    Average change in weight between baseline and 12 weeks


Secondary Outcome Measures :
  1. Mid arm circumference [ Time Frame: baseline to average 12 weeks of age ]
    average change in mid arm circumference between baseline and 12 weeks

  2. Length [ Time Frame: baseline to average 12 weeks of age ]
    average change in length between baseline and 12 weeks

  3. Head circumference [ Time Frame: baseline to average 12 weeks of age ]
    average change in head circumference between baseline and 12 weeks

  4. Caloric intake [ Time Frame: 36 weeks ]
    Average difference in weekly caloric intake between groups

  5. Length of stay [ Time Frame: 36 weeks or discharge ]
    Days from study entry to discharge home

  6. Rates of infants less than 10th percentile for weight [ Time Frame: 36 weeks or discharge ]
    Rates of infants less than 10th percentile for weight at study completion

  7. Change in weight z score [ Time Frame: 36 weeks or discharge ]
    Change in weight z score from study entry to completion

  8. Change in length z score [ Time Frame: 36 weeks or discharge ]
    Change in length z score from study entry to completion

  9. Change in head circumference z score [ Time Frame: 36 weeks or discharge ]
    Change in head circumference z score from study entry to completion


Other Outcome Measures:
  1. Body fat composition [ Time Frame: 36 weeks or discharge ]
    Percentage of body fat composition

  2. Rates of necrotizing enterocolitis (Bell Stage ≥ 2) [ Time Frame: 36 weeks or discharge ]
    Safety outcome: Rates of necrotizing enterocolitis (Bell Stage ≥ 2)

  3. Rates of feeding intolerance [ Time Frame: 36 weeks or discharge ]
    Safety outcome: Rates of feeding intolerance defined as withholding feeds for > 24 hours due to gastrointestinal cause after study entry

  4. Rates of culture proven sepsis [ Time Frame: 36 weeks or discharge ]
    Safety outcome: Rates of blood culture positive sepsis after study entry

  5. Duration of respiratory support [ Time Frame: 36 weeks or discharge ]
    Safety outcome: Duration of respiratory support (oxygen, continuous positive airway pressure/high flow nasal cannula/mechanical ventilation) after study entry

  6. Rates of bronchopulmonary dysplasia [ Time Frame: 36 weeks or discharge ]
    Safety outcome: Rates of bronchopulmonary dysplasia

  7. Rates of moderate to large or symptomatic patent ductus arteriosus [ Time Frame: 36 weeks or discharge ]
    Safety outcome: Rates of moderate to large or symptomatic patent ductus arteriosus after study entry

  8. Rates of adverse safety outcomes combined [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377050


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35249
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Study Director: Waldemar A Carlo, MD University of Alabama at Birmingham
Principal Investigator: Colm Travers, MD University of Alabama at Birmingham
OverallOfficial: Ariel A Salas, MD University of Alabama at Birmingham
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Responsible Party: Colm Travers, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT02377050    
Other Study ID Numbers: UAB NEO 013
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: June 2018
Keywords provided by Colm Travers, University of Alabama at Birmingham:
Nutritional support