Skin and Serum Carotenoids in Preterm Infants Fed on a Formula Supplemented With Carotenoids

Completed · Not applicable

Conditions studied: Retinopathy of Prematurity

In brief

The primary objectives of this study are to compare the serum and skin concentrations of beta-carotene, lutein, and lycopene in preterm infants fed preterm formulas with mixed carotenoids to serum concentrations in preterm infants fed preterm formulas with no added carotenoids and to human milk fed infants. The secondary objective of this study is to evaluate the effects of dietary carotenoids on the developing eye. Stages and zones of retinopathy of prematurity (ROP), retinal function, and retinal characteristics will also be examined.

Key facts

Study ID

NCT00872664

Run by

University of Utah

People needed

36

Starts

2009-09-01

Expected to finish

2013-06-01

Last updated by the study team

2013-12-04

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Birth weight 500-1500 g.
• Less than 33 weeks gestational age (GA) at birth. Maternal dates will be used to estimate GA except in instances where a scan or the neonatologist's estimate differs by two weeks or more. In this instance, the scan or neonatologist's estimate of GA will be used. In the case where one neonatologist's estimate or scan confirms maternal dates and the other estimate does not confirm maternal dates, use the estimate of maternal dates.
• Randomization within 96 hours of initiation of enteral feeding of >/= 60mL/kg/d of HM or formula
• Formula fed infants' feeding consists of no more than 20% from human milk.
• Enteral feeding initiated by 21 days of life (date of birth is Day 0 of life).
• Parent/LAR agrees to allow infants to receive the assigned SSC Advance or NeoSure Advance formula in-hospital starting with the first enteral feed after randomization. If mother is providing breast milk, formula will only be given if there is not sufficient mother's milk.
• Parent/LAR signed the informed consent.
• SGA infants and infants with PDA are eligible to participate.
• Singleton or twin births only. For twins to be eligible, both must meet inclusion criteria.

You may not qualify if…

• Serious congenital abnormalities that may affect growth and development.
• Grade III or IV IVH.
• Maternal incapacity: including maternal cocaine or alcohol abuse during pregnancy or current, or if the mother or infant is currently receiving treatment consistent with HIV therapy.
• History of major surgery (including surgery for NEC).
• Asphyxia (hypoxia and ischemia) as evident by severe and permanent neurological damage.
• Confirmed NEC (modified Bell's stage II or III) or positive blood cultures at the time of randomization
• Infants who are enrolled in this clinical study should be excluded from participation in other concomitant studies. This exclusion criterion can be reviewed on a case-by-case basis. For example, infants will not normally be excluded if only demographic data are being collected or outcome measures on treatment modalities common to current clinical practice are being gathered.

Where it is running

• University of Utah Health Sciences Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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