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

Plagiocephaly Clinical Trial

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

Status Terminated

Clinical 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. 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.

Clinical Trial 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:

1. Infants born at >/= 22 weeks gestation

2. Infant that are </= 7 days of age

3. Infants that receive medical clearance from their healthcare team

4. 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brachycephaly
• Plagiocephaly
• Scaphocephaly

• NCT number: NCT01218087
• Study type: Interventional
• Source: Children's Hospital Boston
• Status: Terminated
• Phase: N/A
• Start date: April 2010
• Completion date: July 2012