Creamy boost: can human milk cream help tiny babies grow?
NCT ID NCT01487928
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether adding human milk cream to breast milk or donor milk could help very low birth weight preterm infants get enough calories. Many preterm babies receive milk that has fewer calories than expected, which can slow their growth. Researchers measured the calorie content of the milk and tracked the infants' weight, length, and head growth over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- human milk cream
- What this could lead to
- If successful, this approach could help preterm infants gain weight and grow better by ensuring their milk has enough calories.
- What could go wrong
- This is a small, completed study with only 78 infants, so results may not apply to all preterm babies. Adding cream may not significantly improve growth or health outcomes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
78 people
The number who actually took part.
- Start date
-
Dec 2011
- Finished
-
Jun 2015
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
Up to 21 days
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Birth weight 750 - 1250g * Able to adhere to expected feeding protocol of mother's own milk/donor milk with fortification of Prolacta® fortifier * Reasonable expectation of survival * Enteral feeding must begin before the 21st day of life Exclusion Criteria: * Decision to not start minimum enteral feed before day 21 of life * Unable to obtain informed consent from parent/guardian prior to the initiation of fortification of enteral feeding * Enrolled in any other clinical study affecting nutritional management during the study period * Presence of clinically significant congenital heart disease or major congenital malformations * Reasonable potential for early transfer to a non-study institution
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Baylor College of Medicine / Texas Children's Hospital
Houston, Texas, 77030, United States
-
UT Health Science Center, San Antonio
San Antonio, Texas, 78229, United States
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