An interventional study of Control Product and Experimental Product 1 in Growth, sponsored by Abbott Nutrition. Not yet recruiting at 14 sites in United States. Per ClinicalTrials.gov, last updated 2024-06-28.
Sponsored by Abbott Nutrition (part of Abbott) · Not applicable, Interventional, and Other
This is a double-blind, randomized, multi-center, controlled, parallel study to evaluate the growth and tolerance of preterm infants fed human milk fortifier (HMF).
Abbott Nutrition is the lead sponsor of 156 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Control Human Milk Fortifier added to human milk feedings
Other: Control Product
Study Human Milk Fortifier added to human milk feedings
Other: Experimental Product 1
Study Human Milk Fortifier added to human milk feedings
Other: Experimental Product 2
Fed from Study Day 1
Fed from Study Day 1
Fed from Study Day 1
Weight
Weight gain per day
Time frame: Study Day 1 to Study Day 29 or Hospital Discharge if first
Length
Length gains per week
Time frame: Study Day 1 to Study Day 15 and Study Day 29
Length
Attained length in cm
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Head Circumference
Head circumference gains per week
Time frame: Study Day 1 to Study Day 15 and Study Day 29
Head Circumference (HC)
Attained HC in cm
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Attained weight in grams
Time frame: Study Day 1, 8, 15, 22, 29 and Hospital Discharge
Weight
Weight gain per day
Time frame: Study Day 1 to Study Day 15
Stool Characteristics
Percent bloody, black, watery, or hard stools
Time frame: Study Day 1 to Study Day 29
Feeding Intolerance
Percent periods NPO, feedings withheld due to gastrointestinal intolerance
Time frame: Study Day 1 to Study Day 29
Full Enteral Feeds
Days to achieve full enteral feeds
Time frame: Study Day 1 to Study Day 29
Blood Chemistries
Electrolytes, minerals, BUN, alkaline phosphatase
Time frame: Study Day 1 to Study Day 29
Medications
Medication usage including frequency and reason for use
Time frame: Study Day 1 to Study Day 29
Length of Stay
Number of days in hospital
Time frame: From birth until Discharge, typically 60 days
Stool Sample
Characterization of microbiota, immunity
Time frame: Study Day 1 to Study Day 29
Blood Sample for Immunity/Inflammation
Cytokines
Time frame: Study Day 1 to Study Day 29
Adverse Events
Number of participants with adverse events (AEs) and concurrent expected events
Time frame: Study Day 1 until Discharge, typically 60 days
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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