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Completed

NCT Number: NCT02377050

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

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Key information

Conditions

Infant Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

1 day–1 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher Volume Feeding Goal

Other

feeding volume goal of 180-200 ml/kg/day

Primary outcomes

  1. Weight gain

    Time frame: baseline to average 12 weeks of age

    Average change in weight between baseline and 12 weeks

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Mar 3, 2015
Registry last updated
Jun 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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