NCT05403684|Completed
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Sponsor study identifier
interventional
214
1 country
1
Study Start
June 13, 2022
Actual (reported)Primary Completion
December 28, 2022
Actual (reported)Study Completion
February 10, 2023
Actual (reported)The primary hypothesis is that very preterm infants between 28 0/7 to 31 6/7 weeks with a birth weight from 1000-1999 grams allocated to the HV breastmilk group (200-240 mL/kg/day) until hospital discharge or 40 weeks' post-menstrual age (PMA), whichever comes first, will have increased growth velocity compared to those given UV breastmilk (140-180 mL/kg/day).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 10, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 23, 2022
Actual (reported)June 3, 2022
Actual (reported)June 13, 2022
Actual (reported)December 28, 2022
Actual (reported)February 10, 2023
Actual (reported)Weight gain
Average change in weight between enrolment (baseline) up to 40 weeks post-menstrual age (PMA) or hospital discharge, whichever comes first.
Baseline up to 40 weeks PMA.
Head circumference
Baseline up to 40 weeks PMA.
Mid-arm circumference
Baseline up to 40 weeks PMA.
Length
Baseline up to 40 weeks PMA.
Length of hospital stay
Baseline up to 40 weeks PMA.
Characterise acceptability, feasibility, and feeding tolerance by breastfeeding women and their infants
Through study completion, on average 8 weeks after enrolment
Neonatal mortality
28 days after birth
Weight at 40 weeks PMA
40 weeks PMA
Postpartum Depression
6-8 weeks postnatal
Infants will receive cup-feeding (to standardize the volume at each feeding) per standard of care guidelines (SOC: 140-180 mL/kg/day) with volumes adjusted for weight and infant age.
Along with SOC volume provided via cup-feeding, the mother will continue to express and feed the baby hind-milk reaching 240 mL/kg/day with volumes adjusted for weight and infant age (200-240 ml/kg/day).
Preterm infants will be given high-volume breastmilk
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
University Teaching Hospital
Lusaka, 10101, Zambia
Waldemar Carlo, MD
University of Alabama at Birmingham
Colm Travers, MD
University of Alabama at Birmingham
Albert Manasyan, MD, MPH
University of Alabama at Birmingham
214 participants (actual enrollment reported by the registry).
First Submitted
May 23, 2022
First Posted
June 3, 2022
Study Start
Contact the study team to confirm eligibility.
June 13, 2022
Actual (reported)Primary Completion
December 28, 2022
Actual (reported)Study Completion
February 10, 2023
Actual (reported)Last Updated
February 14, 2023
Record last verified: 2023-02
Study data will be shared upon a reasonable request to the study PI.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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