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

NCT00872664 | Completed

• 2 other identifiers: 31886ANUS 0805
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Retinopathy of Prematurity

Keywords

ROP; anti-oxidants; carotenoids

Outcome Measures

Primary Outcomes (1)

• The primary objective is to compare the serum and skin levels of carotenoids in preterm infants fed formulas with mixed carotenoids to serum and skin levels in preterm infants fed formulas/human milk with no added carotenoids.

  3 years

Secondary Outcomes (1)

• The secondary objective of this study is to evaluate the effects of dietary carotenoids on the developing eye.

  3 years

Study Arms (2)

formula with added carotenoids

ACTIVE COMPARATOR

Both arms are double-blinded. Infant will be assigned to receive preterm formula with added carotenoids. If infant is receiving human milk then the study formula will only be used as a supplement.

Dietary Supplement: carotenoids

formula without added carotenoids

ACTIVE COMPARATOR

Both arms are double-blinded. This arm will use preterm formula as it is currently available, which is without any carotenoids. If the infant is receiving human milk, then the formula will be used as a supplement as needed.

Dietary Supplement: carotenoids

Interventions

carotenoids DIETARY_SUPPLEMENT

beta-carotene, lycopene, lutein

formula with added carotenoids; formula without added carotenoids

Eligibility Criteria

• Age: Up to 21 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

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

Sponsors & Collaborators

• University of Utah: lead
• Abbott: collaborator

Study Sites (1)

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Retinopathy of Prematurity

Interventions

Carotenoids

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Gary M Chan, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 30, 2009
• First Posted: March 31, 2009
• Study Start: September 1, 2009
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: December 4, 2013

Record last verified: 2013-12

Locations

US (1)