Study discontinued by DSMB due to loss of equipoise.

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.

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).

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

Approximately 800 infants from the 4 participating NICUs were screened; most were excluded for an anticipated length of stay of < 14 days, for medical reasons, and a few parents declined. The total number enrolled out of the approximately 800 screened was 88.

During the second interim analysis, safety monitors recommended early closure due to loss of study equipoise. Clinical staff had been reporting observable differences in infant head shapes for the two study groups.