Weaning Thermoregulatory Support in Preterm Neonates

Stopped early · Not applicable

Conditions studied: Premature Neonates

In brief

Preterm newborns typically must be thermally regulated. In the United States, isolettes (incubators) are used to help them maintain their temperature. Traditionally, the temperature support (i.e. the temperature of the incubator) is decreased slowly according to NICU protocol until the baby is able to maintain its temperature in an open crib, without regard to the status of its feedings. This study will attempt to determine if there is a difference in length of stay, weight gain, and calories needed to gain appropriate weight between a group of newborns whose isolette temperatures are decreased in an aggressive strategy (isolette temperatures are decreased based only on baby's body temperature), and a group of newborns whose isolette temperatures are decreased in a conservative strategy (isolette temperatures are decreased to a minimum temperature and then kept steady until their feeds are at caloric goal and they are taking at least half of their feeds by mouth).

Key facts

Study ID

NCT00769262

Run by

University of Missouri-Columbia

People needed

8

Starts

2008-10-22

Expected to finish

2011-01-26

Last updated by the study team

2017-06-01

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Live born preterm infants from 26 and 0/7 weeks gestation to 34 and 6/7 weeks gestation
• Require thermoregulatory support
• Are able to take feeds
• Are presumed to be able to take oral feeds in the future

You may not qualify if…

• Preterm infants less than 26 and 0/7 weeks gestation
• Preterm infants greater than 34 and 6/7 weeks gestation
• Infants that do not require thermoregulatory support
• Infants that will not be able to have enteral feeds
• Infants with endocrine disease
• Infants with congenital anomalies
• Infants with grade 3 or 4 intraventricular hemorrhage or other severe neurologic disability
• Infants requiring long-term sedation
• Infants that die within 7 days of birth

Where it is running

• Columbia Regional Hospital — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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