Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04492579
Other study ID # 5642622173
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 3, 2018
Est. completion date January 17, 2020

Study information

Verified date July 2020
Source LactaLogics, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study evaluates the effects of providing breastfeeding mothers with Gentle-UHT donor human milk (GHM) after discharge to bridge the gap during delayed onset lactation, to support an exclusive human milk diet and continued breastfeeding through the infant's first week of life. The investigators aim to determine the safety of GHM, and if GHM provided to breastfeeding mothers of outpatient babies with early weight loss will ensure babies adequately gain weight according to age-matched controls.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date January 17, 2020
Est. primary completion date January 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 4 Days
Eligibility Inclusion Criteria:

- Gestational age >36 weeks

- Exclusively fed human milk

- Age <96 hours (4 days)

Exclusion Criteria:

- Previous admittance to the neonatal intensive care unit

- Supplementation of any formula

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Gentle-UHT donor human milk supplementation
Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born >36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.

Locations

Country Name City State
United States LactaLogics, Inc. Port Saint Lucie Florida

Sponsors (2)

Lead Sponsor Collaborator
LactaLogics, Inc Renown Regional Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Weight gain Average weights compared to WHO data 8-9 days of life
Secondary Exclusive human milk diet Rates of infants still on an exclusive human milk diet 8-9 days of life
See also
  Status Clinical Trial Phase
Completed NCT05992753 - Mothers' Breast Milk Expression Experiences, Infant Feeding Attitudes and Perceived Social Support Levels
Completed NCT03674632 - Breastfeed a Better Youngster: the BABY Study N/A
Not yet recruiting NCT06118801 - The Effect of Probiotics Added to the Mother's Diet on Preterm Babies N/A
Completed NCT01892085 - Early Initiation of Milk Expression in Mothers of Very Low Birth Weight Infants N/A
Recruiting NCT05235412 - A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants
Not yet recruiting NCT06164223 - Breast Milk Expression With Virtual Reality N/A
Active, not recruiting NCT02776332 - The Merit Study (Manual Expression pRemature InfanTs) N/A
Recruiting NCT05398367 - Galactagogue Use in Lactating Women With Low Milk Supply N/A
Enrolling by invitation NCT05700162 - The Effect of Showing Photographs, Videos and Live Images of Their Babies to Mothers During Milking N/A
Completed NCT03617549 - Stress and Breast Milk Study In the Neonatal Intensive Care Unit
Completed NCT03583502 - Krill Oil Supplementation: Effects on Breast Milk Composition N/A
Enrolling by invitation NCT03839173 - Growth and Nutritional Status of Very Low Birth Weight Infants Fed a High Protein Exclusive Human Milk Diet N/A
Recruiting NCT03977259 - Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development N/A
Not yet recruiting NCT04639232 - Effect of Consuming a Combination of Probiotic Strains and a Combination of Plant Extracts and a Probiotic Strain on the Production and Nutritional Composition of Breast Milk N/A
Active, not recruiting NCT02832011 - How Effect Olive Oil and Eoprotin on Immunological Parameters and Growth N/A
Completed NCT05599542 - The Effect of Hypno-breastfeeding and Solution-oriented Approach N/A
Completed NCT04729166 - The Management of Perceived Breastmilk Insufficiency N/A
Active, not recruiting NCT04325308 - Early Protein Supplementation in Extremely Preterm Infants Fed Human Milk N/A
Not yet recruiting NCT05902481 - The Effect of Mixed Reality Technology-Based Breastfeeding Counseling on Breastfeeding Success and Self-Efficacy of Women N/A