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 @ 9:50 PM
Ignite Modification Date:
2025-12-24 @ 9:50 PM
NCT ID:
NCT01048632
Eligibility Criteria:
Inclusion Criteria:
* Neonates with HLHS, with plan to undergo the Norwood Procedures
Exclusion Criteria:
* Neonates with a birth weight ≤2.5 kg and gestational age ≥38 weeks (indicating intrauterine growth retardation), gestational age \< 35 weeks (premature infants), and/or chromosomal or recognizable phenotypic syndrome of non-cardiac congenital abnormalities associated with growth failure (e.g. Trisomy 21, Trisomy 13, Noonan's syndrome, Turner's syndrome) will be excluded from enrollment. Neonates who will not be placed on the high risk feeding protocol postoperatively will also be excluded.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
1 Month
Study:
NCT01048632
Study Brief:
Protocol Section:
NCT01048632