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Dietary Supplement
Targeted Nutrition for Premature Infants
N/A
Recruiting
Led By Raylene Phillips, MD
Research Sponsored by Loma Linda University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of birth to date of nicu discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Awards & highlights
Study Summary
This trial will compare the growth of premature infants who are fed either their mother's breast milk with extra nutrients, or a standard diet of formula.
Who is the study for?
This trial is for single preterm infants born between 30 and 35 weeks, whose mothers are at least 18 years old and can provide breast milk. Infants not receiving any breast milk or those with conditions affecting feeding cannot participate.Check my eligibility
What is being tested?
The study tests two ways to help premature babies grow: the standard way NICUs add nutrients to mother's breast milk versus a tailored approach using Enfamil Liquid Human Milk Fortifier.See study design
What are the potential side effects?
Potential side effects may include digestive discomfort or intolerance due to fortification, but specific risks will depend on each infant's condition and response to the added nutrients.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of birth to date of nicu discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of birth to date of nicu discharge or when breast milk is no longer available, whichever comes first, assessed up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Calories in mother's expressed breastmilk
Carbohydrates
Fat content in mother's expressed breastmilk
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Targeted FortificationExperimental Treatment1 Intervention
Mother's breast milk will be fortified with modular additives, namely Amino Acid powder, PolyCal, and safflower oil to meet the individual nutritional needs.
Group II: Standard FortificationActive Control1 Intervention
Mother's breast milk will be fortified using Enfamil Liquid Human Milk Fortifier (LHMF) as per standard feeding protocol defined by LLUCH NICU.
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Who is running the clinical trial?
Loma Linda UniversityLead Sponsor
306 Previous Clinical Trials
260,788 Total Patients Enrolled
5 Trials studying Premature Birth
2,055 Patients Enrolled for Premature Birth
Raylene Phillips, MDPrincipal InvestigatorLoma Linda University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have a birth defect or had surgery that affects my ability to eat.My baby was born early and was the only one born at that time.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Fortification
- Group 2: Targeted Fortification
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have participated in this research trial thus far?
"Indeed, clinicaltrials.gov reveals that this medical test is actively seeking participants. Commencing on August 17th 2022, the study has 200 subject slots available at one facility."
Answered by AI
Are there opportunities for individuals to still join this research experiment?
"Affirmative. Clinicaltrials.gov has information that demonstrates this clinical trial is actively enrolling patients, with the initial post made on August 17th 2022 and its last update occurring on August 23rd 2022. The study requires 200 participants to be recruited from one site."
Answered by AI
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