Status:
TERMINATED
Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Boston Orthotics & Prosthetics
Conditions:
Plagiocephaly
Scaphocephaly
Eligibility:
All Genders
Up to 10 years
Phase:
NA
Brief 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 peri...
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, brady...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01218087
Start Date
April 1 2010
End Date
July 1 2012
Last Update
February 3 2017
Active Locations (1)
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1
Children's Hospital Boston
Boston, Massachusetts, United States, 02115