Weaning Thermoregulatory Support in Preterm Neonates

This study has been withdrawn prior to enrollment.
(insufficient funds)
Sponsor:
Information provided by:
University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00769262
First received: October 8, 2008
Last updated: January 24, 2013
Last verified: January 2013
  Purpose

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).


Condition Intervention
Premature Neonates
Other: Conservative weaning protocol
Other: Aggressive weaning protocol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Conservative Weaning of Thermoregulatory Support on Weight Gain and Length of Stay in Preterm Neonates

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:
  • Length of hospital stay [ Time Frame: Hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Weight gain [ Time Frame: When patient is on 120 cal/kg/day dietary intake ] [ Designated as safety issue: No ]
  • Caloric requirement [ Time Frame: When patient is changed to oral ad lib demand feeds ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2009
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aggressive Weaning
Infants will be weaned from the isolette using our current NICU standard of care.
Other: Aggressive weaning protocol
Infants will be weaned from the isolette based solely on their temperature without regard to feed status (current standard of care in our NICU)
Experimental: Conservative Weaning
Infants will be weaned from the isolette using a modified conservative weaning schedule.
Other: Conservative weaning protocol
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.

  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769262

Locations
United States, Missouri
Columbia Regional Hospital
Columbia, Missouri, United States, 65201
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Sarah B Patton, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Sarah Patton, MD, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00769262     History of Changes
Other Study ID Numbers: 1105137
Study First Received: October 8, 2008
Last Updated: January 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Premature neonates
Thermoregulation
Isolette
Feeding status

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on August 21, 2014