Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00063596
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2003-07-01
Brief Title:
Vitamin A Supplementation in Preterm Infants
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
Vitamin A Therapy in Preterm Infants Vaccine Response
Status:
UNKNOWN
Status Verified Date:
2004-11
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Extremely low birth weight infants have decreased blood levels of Vitamin A This Vitamin A deficiency may increase the risk of infections and chronic lung disease in these infants This study will examine the effects of Vitamin A supplementation in premature babies born weighing less than 1500 grams 33 lbs
Detailed Description:
Vitamin A and its derivative retinoic acid RA have been recognized as important factors in potentiating the immune response and protecting against infection In developing nations Vitamin A deficiency is associated with infectious gastroenteritis and increased susceptibility to a number of infections such as measles RA is an important regulator of cell growth and differentiation and can augment IgM production from core blood mononuclear cells in response to a polyclonal B-cell activator This augmentation in immunoglobulin secretion is mediated by the effects of RA on both T and B cells in part through the production of certain cytokines eg IL-6 and IL-10 important in the terminal differentiation of B-cells to plasma cells In animal models correction of Vitamin A deficiency improves immune response to vaccination
Infants with extremely low birth weight have low plasma and tissue concentrations of Vitamin A Vitamin A supplementation of pre-term infants reduces chronic lung disease and the risk of sepsis Because the immune system of the pre-term infant is immature the response of pre-term infants to Hepatitis B vaccine is diminished compared to full-term babies This study will determine whether Vitamin A supplementation of pre-term infants will enhance the response of these infants to immunization with Hepatitis B vaccine The study will also evaluate the effect of Vitamin A supplementation on survival chronic lung disease and infection rate
Low birth weight pre-term infants will be randomized to receive either Vitamin A supplementation or placebo The Vitamin A treatment group will receive 5000 IU of Vitamin A retinyl palmitate by intramuscular injection 3 times weekly for 28 days starting on postnatal day 2 To avoid pain and discomfort the placebo group will receive a sham procedure rather than a placebo saline injection The staff of the neonatal intensive care unit will retain the responsibility for decisions regarding the use of other therapies such as parental fluids mechanical ventilation glucocorticoids hyperalimentation and blood replacement All infants will be assessed for potential Vitamin A toxicity While in the neonatal intensive care unit infants will have blood tests at Days 0 14 30 and 60 After discharge from the neonatal intensive care unit patients return for clinic assessment and blood samples at Months 4 6 and 9 Infants will be given Hepatitis B vaccine at 2 4 and 6 months chronological age Primary outcome measures will include Hepatitis B antibody levels chronic lung disease rate of infection while in the neonatal intensive care unit and the incidence and severity of infections during the first 9 months of life
Infants with extremely low birth weight have low plasma and tissue concentrations of Vitamin A Vitamin A supplementation of pre-term infants reduces chronic lung disease and the risk of sepsis Because the immune system of the pre-term infant is immature the response of pre-term infants to Hepatitis B vaccine is diminished compared to full-term babies This study will determine whether Vitamin A supplementation of pre-term infants will enhance the response of these infants to immunization with Hepatitis B vaccine The study will also evaluate the effect of Vitamin A supplementation on survival chronic lung disease and infection rate
Low birth weight pre-term infants will be randomized to receive either Vitamin A supplementation or placebo The Vitamin A treatment group will receive 5000 IU of Vitamin A retinyl palmitate by intramuscular injection 3 times weekly for 28 days starting on postnatal day 2 To avoid pain and discomfort the placebo group will receive a sham procedure rather than a placebo saline injection The staff of the neonatal intensive care unit will retain the responsibility for decisions regarding the use of other therapies such as parental fluids mechanical ventilation glucocorticoids hyperalimentation and blood replacement All infants will be assessed for potential Vitamin A toxicity While in the neonatal intensive care unit infants will have blood tests at Days 0 14 30 and 60 After discharge from the neonatal intensive care unit patients return for clinic assessment and blood samples at Months 4 6 and 9 Infants will be given Hepatitis B vaccine at 2 4 and 6 months chronological age Primary outcome measures will include Hepatitis B antibody levels chronic lung disease rate of infection while in the neonatal intensive care unit and the incidence and severity of infections during the first 9 months of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None