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Weaning Thermoregulatory Support in Preterm Neonates

NCT00769262 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2017-06-01

No results posted yet for this study

Summary

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).

Conditions

  • Premature Neonates

Interventions

OTHER

Conservative weaning

Infants will not be weaned from the isolette until their feeds are at full calorie goal (120 kcal/kg/day) and at least half of feeds are taken orally.

OTHER

Aggressive Weaning

Infants will be weaned from the isolette based solely on their temperature without regard to feed status (current standard of care in our NICU)

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Principal Investigators

  • Sarah B Patton, MD · University of Missouri-Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-22
Primary Completion
2011-01-26
Completion
2011-01-26

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00769262 on ClinicalTrials.gov