Weaning Preterm Infants at 1500 Grams From Incubators
Primary Purpose
Preterm Infants
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Weaning Preterm Infants from an incubator
Sponsored by

About this trial
This is an interventional treatment trial for Preterm Infants focused on measuring energy expenditure, hypothermia, body temperature, weaning, preterm infants
Eligibility Criteria
Inclusion Criteria:
- stable preterm infants weighing ≤1500 g
- fully enterally fed, and without supplemental oxygen
- steroid or antibiotics treatment
- at the postnatal age of ≥ 2 weeks were included
- infants < than 2 weeks of age
Exclusion Criteria:
- ventilated infants or those requiring oxygen supplementation
- parenteral nutrition
- antibiotic treatment or steroids treatment were excluded
Sites / Locations
- Neonatology department Tel Aviv Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
weaning at 1500 g
weaning at 1600 g
Arm Description
weaning infants from an incubator at 1500 g
weaning infants from an incubator at 1600 g
Outcomes
Primary Outcome Measures
successful and safe weaning from convective incubator of stable preterm infants to a warming bassinet at body weight of 1500g compared with 1600g.
Secondary Outcome Measures
Resting energy expenditure REE (kcal/kg/24h) measurements
Full Information
NCT ID
NCT01083303
First Posted
July 2, 2009
Last Updated
August 1, 2012
Sponsor
Tel-Aviv Sourasky Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01083303
Brief Title
Weaning Preterm Infants at 1500 Grams From Incubators
Official Title
A Randomized Trial of Weaning Preterm Infants at 1500g From Incubators: Effect on Failure to Wean, Weight Gain and Energy Expenditure
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Background: The weight at which infants are weaned from incubators varies among neonatal units.
Objective: To determine the effect on weight gain, temperature stability and resting energy expenditure (REE) of weaning infants at body weight of 1500 g versus 1600 g.
Design/Methods: infants will be randomized to incubator weaning at the weight of 1500 g or 1600 g. Preterm infants 1500 g birth weight, fully enterally fed, and without supplemental oxygen, at the postnatal age of 2 weeks will be included. Infants will be weaned to a warming bassinet (Babytherm 8000, Dräger) set to keep a mattress temperature of 37°C while decreasing it gradually to room temperature. Failure to wean is defined as core body temperature of < 36.1°C. Data collection included skin and rectal temperature obtained before weaning, and at 1/2, 1, 2, 6, 24, and 48 hours after weaning, weekly weight gain (g/kg/d). REE (kcal/kg/24h) will be measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after weaning.
Detailed Description
Eligible infants will be randomized by computer generated random numbers, to either the study group weaned at 1500 g or the control group weaned at 1600 g. Both groups will be weaned to a warming bassinet (Babytherm 8000, Drager). The Babytherm 8000 WB is an open care infant warming system with a warmed gel mattress with temperature control . The system is set to keep the mattress temperature of 37 degrees Celsius while decreasing it gradually to 32 0C and shutting the system off. On transfer to the Babytherm infants are dressed with a hat and two vests. Only after the infant maintained a normal body temperature under these conditions he could be transferred to an open bassinet. Failure to wean was defined as core body temperature of <36.10C.
Data collection included skin and rectal temperature obtained before weaning, and at 1/2, 1, 2, 6, 24, and 48 hours after weaning, daily and weekly weight gain (g/kg/d). Resting Energy Expenditure- REE (kcal/kg/24h) is measured by indirect calorimetry (Deltatrac II, Finland) before and 24 hours after weaning to the warming bassinet.
Data Collection included: PR temperature after 30 min, 60 min, 2 hours, 6 hours, 24 hours, after which temperatures were taken 4-hourly until 48 hours (degrees C), skin (axillary) temperature (degrees C), after 30 min, 60 min, 2 hours, 6 hours, and than again every 4 hours until 48 hours. REE (kcal/kg/24h)rate of hypothermia requiring return to the incubator, weight gain after 24 hours of weaning and over 1 week.( g/kg/d),time to discharge ( days).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infants
Keywords
energy expenditure, hypothermia, body temperature, weaning, preterm infants
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
weaning at 1500 g
Arm Type
Experimental
Arm Description
weaning infants from an incubator at 1500 g
Arm Title
weaning at 1600 g
Arm Type
Active Comparator
Arm Description
weaning infants from an incubator at 1600 g
Intervention Type
Behavioral
Intervention Name(s)
Weaning Preterm Infants from an incubator
Intervention Description
Eligible infants are to be randomized by computer generated random numbers to either the study group weaned at 1500 gr. or the control group weaned at 1600 gr. Both groups were weaned to a warming bassinet.
Primary Outcome Measure Information:
Title
successful and safe weaning from convective incubator of stable preterm infants to a warming bassinet at body weight of 1500g compared with 1600g.
Time Frame
Ten days
Secondary Outcome Measure Information:
Title
Resting energy expenditure REE (kcal/kg/24h) measurements
Time Frame
Fourty eight hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
stable preterm infants weighing ≤1500 g
fully enterally fed, and without supplemental oxygen
steroid or antibiotics treatment
at the postnatal age of ≥ 2 weeks were included
infants < than 2 weeks of age
Exclusion Criteria:
ventilated infants or those requiring oxygen supplementation
parenteral nutrition
antibiotic treatment or steroids treatment were excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaul Dollberg, MD
Organizational Affiliation
Tel-Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Neonatology department Tel Aviv Medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
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Weaning Preterm Infants at 1500 Grams From Incubators
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