Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-24 @ 7:12 PM
NCT ID:
NCT00342303
Eligibility Criteria:
* INCLUSION CRITERIA:
Newborns with birth weights appropriate for their gestational age born at 28, 32, 36 and 40 weeks gestation that are recovering from common neonatal morbidity will be recruited to enter the study before 5 days of age. This disease condition will not be life threatening at the time of study.
The typical disease conditions expected based on the pilot phase of study are infants recovering from asphyxia, infants recovering from transient tachypnea, infants recovering from suspect pneumonia, infants recovering from hyaline membrane disease.
Hyperbilirubinemia in conjunction with disease condition will not be a reason for exclusion.
Newborns with birth weights below the tenth percentile of the weight distribution for a given gestational age born at 30-34 and 36-38 weeks gestation.
Will include infants born at 28 to 40 weeks who are free of major neonatal morbidity and will be recruited to enter the study at 10 days of age.
EXCLUSION CRITERIA:
Maternal factors which may affect their fatty acid metabolism of the neonate.
* Vegetarian or vegan diet during pregnancy
* Metabolic disease which may affect essential fatty acid status of the fetus (hyperlipidemia, diabetes)
Postnatal factors:
Birth weight inadequate for gestational age (birth weight below the 10th percentile or above the 90th percentile for gestational age)
Significant acute neonatal morbidity which interferes with normal lipid metabolism during the study period. Infants who are recovering from common neonatal morbidities that do not have obvious effects on elongase/desaturase activity will not be excluded.
Feeding other than prescribed for the study.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00342303
Study Brief:
Protocol Section:
NCT00342303