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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01218087
• Other study ID #: 08120584
• Status: Terminated
• Phase: N/A
• First received: September 30, 2010
• Last updated: July 29, 2015
• Start date: April 2010
• Est. completion date: July 2012

Study information

• Verified date: July 2015
• Source: Children's Hospital Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

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.

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

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 10 Days

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. 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

2. 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

3. Infants with a craniofacial anomaly, cervical anomaly, or critical airway infants

4. Infants with Cutis Aplasia or significant skin breakdown to the scalp, because the cranial cup may worsen a preexisting condition

5. Infants with a prenatal diagnosis of craniosynostosis

6. Infants deemed not suitable for participation by the attending neonatologist

7. 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

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

Intervention

Device:
• Cranial cup device and Moldable positioner
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 device
This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.

Locations

Country	Name	City	State
United States	Children's Hospital Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Boston	Boston Brace

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 120 days	No
Secondary	Incidence of Cardiorespiratory	daily log of cardiorespiratory events (apnea, bradycardia, oxygen desaturation) collected on a daily positioning log at the infant's bedside	daily up to 120 days	Yes