Weaning Thermoregulatory Support in Preterm Neonates

NCT00769262 | Terminated

• 1 other identifier: 1105137
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Premature neonates; Thermoregulation; Isolette; Feeding status

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  Hospital discharge

Secondary Outcomes (2)

• Weight gain

  When patient is on 120 cal/kg/day dietary intake

• Caloric requirement

  When patient is changed to oral ad lib demand feeds

Study Arms (2)

Aggressive Weaning

ACTIVE COMPARATOR

Infants will be weaned from the isolette using our current NICU standard of care.

Other: Aggressive Weaning

Conservative Weaning

EXPERIMENTAL

Infants will be weaned from the isolette using a modified conservative weaning schedule.

Other: Conservative weaning

Interventions

Conservative weaning OTHER

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.

Conservative Weaning

Aggressive Weaning OTHER

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

Aggressive Weaning

Eligibility Criteria

• Age: 1 Day+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

Columbia Regional Hospital

Columbia, Missouri, 65201, United States

Location

Study Officials

• Sarah B Patton, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2008
• First Posted: October 9, 2008
• Study Start: October 22, 2008
• Primary Completion: January 26, 2011
• Study Completion: January 26, 2011
• Last Updated: June 1, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)