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NCT02422511 · ClinicalTrials.gov registry record · NA

Genomic Sequencing for Childhood Risk and Newborn Illness

A NA study, sponsored by Brigham and Women's Hospital.

Completed
Registry status
NA
Development phase
1,205
Enrollment target

NCT02422511: Completed NA study, sponsored by Brigham and Women's Hospital.

NCT02422511 is a NA study that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 1,205 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (14% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02422511, a NA study, has completed, sponsored by Brigham and Women's Hospital.

COMPLETED
Registry status
NA
Development phase
1,205 participants
Enrollment target

Study Summary

The Genomic Sequencing for Childhood Risk and Newborn Illness (the BabySeq Project) is a research study exploring the use of genomic sequencing in newborns. The National Institutes of Health is funding this study. The investigators will enroll 240 healthy infants and their parents from the Brigham and Women's Hospital (BWH) Well Newborn Nursery and 240 sick infants and their parents at Boston Children's Hospital (BCH) or the BWH Neonatal Intensive Care Unit (NICU). A small blood sample will be collected from each infant and genome sequencing may be performed. Six weeks later, results are returned and explained. Over 12 months the investigators are studying the experiences of parents and pediatricians of infants who receive sequencing to help understand how best to use genomics in pediatric care.

Primary Outcome

Days spent in inpatient care from disclosure of randomization status / genomic sequencing results through 10 months post-disclosure. Services were identified through a combination of chart note review, medical record review and participant surveys.

Interventions

  • GENETIC Genomic sequencing
  • OTHER Family history report

Trial Details

FieldValue
Enrollment Target 1,205 participants
Start Date 2015-05
Est. Completion 2021-08-05
Phase NA
Brigham and Women's Hospital

937 total trials

What the finished NCT02422511 record still lists

NCT02422511 is an interventional study that assigns participants to a tested intervention. Its 1,205 participants enrollment target places it among the larger protocols in the corpus, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (14% lower).

The record links to 0 conditions, and to 2 interventions - of which Genomic sequencing is the first listed.

NCT02422511 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02422511 about?

NCT02422511 is a clinical study titled "Genomic Sequencing for Childhood Risk and Newborn Illness". The Genomic Sequencing for Childhood Risk and Newborn Illness (the BabySeq Project) is a research study exploring the use of genomic sequencing in newborns. The National Institutes of Health is funding this study. The investigators will enroll 240 healthy infants and their parents from the Brigham ...

What is the current status of trial NCT02422511?

This trial is currently completed. It is a NA study. The enrollment target is 1,205 participants. The study started on 2015-05. Estimated completion is 2021-08-05.

What interventions are being tested in trial NCT02422511?

The interventions under investigation include: Genomic sequencing (GENETIC), Family history report (OTHER).

Who is sponsoring clinical trial NCT02422511?

This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02422511's enrollment target sits among peer trials

1,205 83rd of 2000 higher than 1,918 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02422511, the US trial registry maintained by the National Library of Medicine. NCT02422511 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.