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NCT03184441 · ClinicalTrials.gov registry record · NA

Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants

A NA study, sponsored by Boston Children's Hospital.

Completed
Registry status
NA
Development phase
11
Enrollment target

NCT03184441: Completed NA study, sponsored by Boston Children's Hospital.

NCT03184441 is a NA study that has completed, run by Boston Children's Hospital. The registered enrollment target is 11 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03184441, a NA study, has completed, sponsored by Boston Children's Hospital.

COMPLETED
Registry status
NA
Development phase
11 participants
Enrollment target

Study Summary

This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing \< 1 kilogram.

Primary Outcome

Frequency of participants with adverse events reported using the Premie Pouch Adverse Event Data Collection Tool.

Interventions

  • DEVICE Premie Pouch

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2016-06
Est. Completion 2019-03
Phase NA
Boston Children's Hospital

462 total trials

What the finished NCT03184441 record still lists

NCT03184441 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 1 intervention - of which Premie Pouch is the first listed.

NCT03184441 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03184441 about?

NCT03184441 is a clinical study titled "Premie Pouch to Manage Deformational Plagiocephaly in Very Low Birth Weight Infants". This pilot project proposes to develop and test a new device to manage (defined as resolving, prohibiting, inhibiting or preventing) the development of Deformational Plagiocephaly (DP) in prematurely born infants weighing \< 1 kilogram.

What is the current status of trial NCT03184441?

This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2016-06. Estimated completion is 2019-03.

What interventions are being tested in trial NCT03184441?

The interventions under investigation include: Premie Pouch (DEVICE).

Who is sponsoring clinical trial NCT03184441?

This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03184441's enrollment target sits among peer trials

11 1927th of 2000 higher than 74 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 NCT03184441, the US trial registry maintained by the National Library of Medicine. NCT03184441 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.