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:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT02927093
Eligibility Criteria:
Inclusion Criteria:
Cases
Liveborn, singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting one or more of the following criteria:
* Two consecutive SBR measures above the exchange transfusion threshold of the phototherapy charts for gestational age
* SBR levels rising \> 8.5 µmol/L per hour
* One or more neurological signs compatible with ABE in the absence of other known neurological condition and in the presence of confirmed NH
Controls
Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU presenting all of the following criteria:
* At least one SBR between the moderate and the severe threshold of the phototherapy charts for gestational age
* No SBR above the severe threshold at any time point
* No reported abnormal neurological signs (i.e. convulsions, abnormal cry or tone)
Each case who has been discharged alive from the SCBU will be matched to one control from the same clinic, sex, gestational age, season of birth and hospitalized within the same month and the clinical and neurodevelopment of both children will be conducted once.
Exclusion Criteria:
* Stillborn
* Twins
* Liveborn \< 28 weeks gestation
* Major congenital malformation
* Liveborn singleton, ≥28 weeks gestation, hospitalized outside SMRU SCBU
* Liveborn singleton, ≥28 weeks gestation, hospitalized at SMRU SCBU without SBR done or with all SBR below the moderate threshold of the phototherapy charts for gestational age
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
28 Weeks
Study:
NCT02927093
Study Brief:
Protocol Section:
NCT02927093