Terminated NA INTERVENTIONAL 2-arm NCT01218087

Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU

Sponsor: Boston Children's Hospital

Conditions Brachycephaly Plagiocephaly Scaphocephaly

Interventions Cranial cup device and Moldable positioner Moldable positioner device

Updated 8 times since 2017 Last updated: Dec 8, 2016 Started: Apr 30, 2010 Primary completion: Jul 31, 2012 Completion: Jul 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Study discontinued by DSMB due to loss of equipoise.

Other terminated trials from Boston Children's Hospital

See all terminations from Boston Children's Hospital

This NA trial investigates Brachycephaly and Plagiocephaly and is currently terminated or withdrawn. Boston Children's Hospital leads this study, which shows 8 recorded versions since 2010 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Terminated NA
Jul 2024 — Sep 2024 [monthly]

Terminated NA
Dec 2021 — Jul 2024 [monthly]

Terminated NA
Jan 2021 — Dec 2021 [monthly]

Terminated NA
Sep 2020 — Jan 2021 [monthly]

Terminated NA

▶ Show 3 earlier versions

Jan 2019 — Sep 2020 [monthly]

Terminated NA
Jun 2018 — Jan 2019 [monthly]

Terminated NA
Jan 2017 — Jun 2018 [monthly]

Terminated NA

First recorded

Apr 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Boston Children's Hospital
Boston Orthotics & Prosthetics

Data source: Boston Children's Hospital

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Boston, United States