PlagiocephalyNCT01218087
Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
A study testing Cranial cup device and Moldable positioner and Moldable positioner device in people with Plagiocephaly and Scaphocephaly, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant's head rests on a firm or semi-firm surface for a prolonged period of time. Read more about this study
- Who is it for?
- Ages Up to 10 days
- Conditions the study is for
- Plagiocephaly, Scaphocephaly, Brachycephaly
- What is being tested?
- Cranial cup device and Moldable positioner and Moldable positioner device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 10 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born at >/= 22 weeks gestation
- Infant that are </= 7 days of age
- Infants that receive medical clearance from their healthcare team
- Infants that have an estimated minimum NICU length of stay = / > 14 days from the time of enrollment
Who cannot join
- Infants that require only prone positioning to maintain airway patency (such as those with Pierre Robin Syndrome/Sequence) will not be eligible to participate; this is because infants must be able to lie supine for at least part of the day to use the cranial cup
- Infants requiring medical devices such as a continuous ventricular drain, subgaleal shunt, or intravenous catheters (unless placement of the IV is temporary) prevent proper positioning using the cranial cup
- Infants with a craniofacial anomaly, cervical anomaly, or critical airway infants
- Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the cranial cup may worsen a preexisting condition
- Infants with a prenatal diagnosis of craniosynostosis
- Infants deemed not suitable for participation by the attending neonatologist
- Infants that are to be transferred to a non-participating hospital within 14 days of enrollment as this timeframe may not be adequate to show a difference in head shapes
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant's head rests on a firm or semi-firm surface for a prolonged period of time. Premature infants are more likely to have a positional head shape deformity because they may spend longer periods of time in a crib. Infants participating in this study will be randomly assigned to either standard treatment, which is a moldable positioner device, or to a cranial cup device and moldable positioner for positioning. The purpose of this prospective single-blinded randomized clinical trial will be to evaluate the effectiveness of the cranial cup in preventing positional head shape deformity in the NICU patient population.
Read the detailed description
The primary outcome for this study will be cranial index and cranial symmetry measured at hospital discharge; the secondary outcome measure is the incidence of oxygen desaturation events (apnea, bradycardia and oxygen desaturation).
The pilot study was undertaken to evaluate if the cranial cup can be successfully incorporated into the NICU patient care regime, the pilot study included 5 infants.
The main trial enrollment was estimated to be 160 infants from 4 centers. Upon enrollment infants will be randomized to one of two study groups
- Cranial cup and moldable positioner
- Moldable positioner
Inclusion criteria:
There are several inclusion criteria for participation in the study:
- Infants born at >/= 22 weeks gestation
- Infant that are </= 7 days of age
- Infants that receive medical clearance from their healthcare team
- Infants that have an estimated minimum NICU length of stay = / > 14 days from the time of enrollment
Infants were stratified by study site and weight at enrollment (< 1000 grams versus = / > 1000 grams).
- Conditions
- Plagiocephaly, Scaphocephaly, Brachycephaly
- Being tested
- Cranial cup device and Moldable positioner, Moldable positioner device
- Keywords
- Positional Head Shape Deformity
- Medical subject headings
- Plagiocephaly, Craniosynostoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial cup device and Moldable positionerDevice
The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in hospitalized infants
Moldable positioner deviceDevice
This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.
| Study group | Role | What they receive |
|---|---|---|
| Cranial cup device and Moldable positioner device | Experimental | The cranial cup for 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours Receives: Device: Cranial cup device and Moldable positioner; Device: Moldable positioner device |
| Moldable positioner device | Active comparator | Moldable positioner device was used for positioning infants for 24/24 hours Receives: Device: Moldable positioner device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial Abnormalities Were Measured at Hospital Discharge
Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.
Measured: up to 120 days
Secondary outcomes (1)
Incidence of Cardiorespiratory
daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside
Measured: daily up to 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2012
- Study completionJul 2012
Why it stopped: Study discontinued by DSMB due to loss of equipoise.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PlagiocephalyStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Orthotics & Prosthetics
- Responsible party
- Principal investigator, Michele DeGrazia, Boston Children's Hospital
- Investigators
- Michele DeGrazia, PhD, NNP, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218087
- Sponsor's protocol ID
- 08120584
- Status last verified
- Dec 2016
- First submitted
- 30 Sep 2010
- Last updated
- 3 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
- ClinicalTrials.gov ID
- NCT01218087
- Acronym / sponsor ID
- 08120584
- Conditions
- Plagiocephaly, Scaphocephaly, Brachycephaly
- Keywords
- Positional Head Shape Deformity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study discontinued by DSMB due to loss of equipoise.
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Boston Orthotics & Prosthetics
- Study start
- Apr 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 11 Oct 2010 (estimated)
- Results
- Posted 26 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many hospitalized infants can develop a flattening of the back or sides of their head. This condition develops gradually when an infant's head rests on a firm or semi-firm surface for a prolonged period of time. Premature infants are more likely to have a positional head shape deformity because they may spend longer periods of time in a crib. Infants participating in this study will be randomly assigned to either standard treatment, which is a moldable positioner device, or to a cranial cup device and moldable positioner for positioning. The purpose of this prospective single-blinded randomized clinical trial will be to evaluate the effectiveness of the cranial cup in preventing positional head shape deformity in the NICU patient population.
Detailed description
The primary outcome for this study will be cranial index and cranial symmetry measured at hospital discharge; the secondary outcome measure is the incidence of oxygen desaturation events (apnea, bradycardia and oxygen desaturation).
The pilot study was undertaken to evaluate if the cranial cup can be successfully incorporated into the NICU patient care regime, the pilot study included 5 infants.
The main trial enrollment was estimated to be 160 infants from 4 centers. Upon enrollment infants will be randomized to one of two study groups
- Cranial cup and moldable positioner
- Moldable positioner
Inclusion criteria:
There are several inclusion criteria for participation in the study:
- Infants born at >/= 22 weeks gestation
- Infant that are </= 7 days of age
- Infants that receive medical clearance from their healthcare team
- Infants that have an estimated minimum NICU length of stay = / > 14 days from the time of enrollment
Infants were stratified by study site and weight at enrollment (< 1000 grams versus = / > 1000 grams).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranial cup device and Moldable positioner device | Experimental | Device: Cranial cup device and Moldable positioner, Device: Moldable positioner deviceThe cranial cup for 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours |
| Moldable positioner device | Active comparator | Device: Moldable positioner deviceMoldable positioner device was used for positioning infants for 24/24 hours |
Who may qualify
- Ages
- Up to 10 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants born at >/= 22 weeks gestation
- Infant that are </= 7 days of age
- Infants that receive medical clearance from their healthcare team
- Infants that have an estimated minimum NICU length of stay = / > 14 days from the time of enrollment
Key exclusion criteria (7 listed)
- Infants that require only prone positioning to maintain airway patency (such as those with Pierre Robin Syndrome/Sequence) will not be eligible to participate; this is because infants must be able to lie supine for at least part of the day to use the cranial cup
- Infants requiring medical devices such as a continuous ventricular drain, subgaleal shunt, or intravenous catheters (unless placement of the IV is temporary) prevent proper positioning using the cranial cup
- Infants with a craniofacial anomaly, cervical anomaly, or critical airway infants
- Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the cranial cup may worsen a preexisting condition
- Infants with a prenatal diagnosis of craniosynostosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial cup device and Moldable positionerThe cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in hospitalized infants | Device | Cranial cup device and Moldable positioner device |
| Moldable positioner deviceThis moldable positioning device was used 24/24 hours as a comparison to the cranial cup device. | Device | Cranial cup device and Moldable positioner device, Moldable positioner device |
Primary outcome
Cranial Abnormalities Were Measured at Hospital Discharge
Time frame: up to 120 days
Cranial abnormality measurements were obtained at hospital discharge by orthotists blinded to the study group assignment. Cranial abnormalities include both cranial index measures and cranial symmetry measures. Cranial index (normal measurement between 73%-85%) was obtained dividing the head width (M-L) by length (A-P) then multiplying it by 100%. Cranial symmetry (normal measurement of<8mm) was obtained by calculating the difference in the right and left anterior-posterior measures.
1 secondary outcome
Incidence of Cardiorespiratory
Time frame: daily up to 120 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michele DeGrazia, PhD, NNP principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial cup device and Moldable positioner and Moldable positioner device in people with Plagiocephaly and Scaphocephaly, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cranial Abnormalities Were Measured at Hospital Discharge (time frame: up to 120 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017.