Incubator Weaning of Moderately Preterm Infants

NICHD Neonatal Research Network

Status: Completed

Conditions: Infant, Newborn; Infant, Moderate Preterm

Treatments: Procedure: Weaning from an incubator at a lower weight (1600 grams); Procedure: Weaning from an incubator at a higher weight (1800 grams)

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT02160002

NICHD-NRN-0054

Details and patient eligibility

About

The objective of this proposal is to evaluate whether weaning from an incubator to a crib at lower versus higher weight, 1600g or 1800g will result in shorter length of hospital stay among moderately preterm infants.

The hypothesis of this study is that length of hospital stay (from birth to discharge) will be decreased among moderate preterm infants weaned from an incubator to an open crib at a lower versus higher weight, 1600g vs. 1800g.

Enrollment: 366 patients

Sex: All

Ages: 29 to 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Gestational age 29 0/7 to 33 6/7 weeks at birth
• Birth weight less than 1600 grams
• Greater than 48 hours of age
• Current weight less than 1540 grams
• In an incubator

Exclusion criteria

• Receiving phototherapy
• Receiving respiratory support (including CPAP, ventilation, HFNC > 2 LPM)
• Receiving blood pressure support
• Designated for transfer to referral hospital while in incubator
• Known major congenital or chromosomal anomaly

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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366 participants in 2 patient groups

Lower Weight (1600 grams)

Active Comparator group

Description:

Weaning from an incubator at a lower weight (1600 grams)

Treatment:

Procedure: Weaning from an incubator at a lower weight (1600 grams)

Higher Weight (1800 grams)

Active Comparator group

Description:

Weaning from an incubator at a higher weight (1800 grams)

Treatment:

Procedure: Weaning from an incubator at a higher weight (1800 grams)