ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02377050
Date of registration:	01/12/2014
Prospective Registration:	Yes
Primary sponsor:	University of Alabama at Birmingham
Public title:	Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Scientific title:	Randomized Controlled Trial of Higher-Volume Feedings in Preterm Neonates
Date of first enrolment:	January 2015
Target sample size:	224
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02377050
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
United States

Contacts

Name:	Colm Travers, MD
Address:
Telephone:
Email:
Affiliation:	University of Alabama at Birmingham

Name:	Waldemar A Carlo, MD
Address:
Telephone:
Email:
Affiliation:	University of Alabama at Birmingham

Name:	Ariel A Salas, MD
Address:
Telephone:
Email:
Affiliation:	University of Alabama at Birmingham

Key inclusion & exclusion 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

Age minimum: N/A
Age maximum: 1 Month
Gender: All

Health Condition(s) or Problem(s) studied

Infant Premature

Intervention(s)

Other: Higher Volume Feeding Goal

Primary Outcome(s)

Weight gain [Time Frame: baseline to average 12 weeks of age]

Secondary Outcome(s)

Change in weight z score [Time Frame: 36 weeks or discharge]

Head circumference [Time Frame: baseline to average 12 weeks of age]

Length of stay [Time Frame: 36 weeks or discharge]

Change in head circumference z score [Time Frame: 36 weeks or discharge]

Change in length z score [Time Frame: 36 weeks or discharge]

Mid arm circumference [Time Frame: baseline to average 12 weeks of age]

Rates of infants less than 10th percentile for weight [Time Frame: 36 weeks or discharge]

Length [Time Frame: baseline to average 12 weeks of age]

Caloric intake [Time Frame: 36 weeks]

Secondary ID(s)

UAB NEO 013

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.