Recruiting

Observational Study

Sponsor:

Boston Children's Hospital

Code:

NCT07165938

Conditions

Neonatal Encephalopathy

Hypoxic Ischaemic Encephalopathy (HIE)

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

Investigators at Boston Children's Hospital are conducting research in order to better understand the genetic factors which may contribute to neonatal encephalopathy (NE) and related disorders. These findings may help explain the broad spectrum of clinical features and outcomes seen in individuals with a history of NE.

Conditions

Neonatal Encephalopathy

Hypoxic Ischaemic Encephalopathy (HIE)

Study ID

NCT07165938

Start date

Feb 4, 2026

Status verified date

Mar, 2026

Completion date

Sep, 2035

Anticipated

Primary completion date

Sep, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Proband Criteria:

Inclusion Criteria:

  • Diagnosed with neonatal encephalopathy during the neonatal period as documented in the electronic medical record
  • Less than 6 years old at the time of study enrollment
  • Patient at Boston Children's Hospital

Exclusion Criteria:

  • Genetic cause of NE already identified
  • Deceased prior to enrollment

Parent criteria:

Inclusion Criteria:

\- Biological parent of eligible proband (see above)

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Neonatal Encephalopathy

Individuals with a history of NE who are less than 6 years old at the time of enrollment and available biological parents. Must be followed clinically at Boston Children's Hospital. Research genomic sequencing with CLIA confirmation of diagnostic findings. Those with an existing genetic diagnosis or who are deceased prior to enrollment are ineligible.

Primary outcome measure

  • Diagnostic yield [ Time Frame: 10 years ]

Central Contacts and Locations

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

D'Gama Lab

617-355-5254dgamalab@childrens.harvard.edu

Principal Investigator:

Alissa D'Gama, MD, PhD

More Information

Sponsor

Boston Children's Hospital

Last update posted

Mar 11, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Children's Hospital on 2026-03-11.