Cranial Cup Use for the Prevention of Positional Head Shape Deformity in the NICU
| Status: | Terminated |
|---|---|
| Conditions: | Other Indications, Women's Studies |
| Therapuetic Areas: | Other, Reproductive |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2010 |
| End Date: | July 2012 |
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.
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.
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).
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).
Inclusion Criteria:
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
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
We found this trial at
1
site
Click here to add this to my saved trials
