Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01083303
Study type Interventional
Source Tel-Aviv Sourasky Medical Center
Contact
Status Completed
Phase N/A
Start date May 2005
Completion date May 2009

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02159534 - Primebrain Stimulation N/A
Recruiting NCT01813682 - Effect of Iron-fortified TPN on Preterm Infants Anemia N/A
Not yet recruiting NCT01615523 - Executive Function in Preterm Born Children: An Integrative Approach From Genetics to Brain Function N/A
Completed NCT02103777 - High Versus Low Dose of Caffeine for Apnea of Prematurity Phase 3
Recruiting NCT06201962 - Effect of Massage and Foot Reflexology on Newborns' Sleep N/A
Completed NCT05230706 - Light/Dark Cycle Promotes Weight Gain in Preterm Infants N/A
Recruiting NCT05138276 - Effect of Autologous Cord Blood Mononuclear Cells for Digestive System in Preterm Neonates Early Phase 1
Terminated NCT01430832 - Developmental Outcomes of Extreme Prematurity, 5-15 Years Postpartum
Not yet recruiting NCT02872350 - Prognostic Contribution of Abdominal Ultrasound in Necrotizing Enterocolitis in Preterm Infants Less Than 33SA. N/A
Recruiting NCT01786759 - Hepatic Function and Bile Acid in Preterm Infants Receiving Parenteral Lipids Emulsion Phase 4
Completed NCT00838474 - The Effect of Music by Mozart on Energy Expenditure in Growing Preterm Infants N/A
Completed NCT05656677 - Parental Involvement in Pain Reducing Measures N/A
Active, not recruiting NCT01487187 - The Effect of Cord Milking on Hemodynamic Status of Preterm Infants N/A
Completed NCT00838188 - Energy Expenditure in Breast and Bottle Feeding Preterm Infants Fed Their Mother's Breast Milk N/A
Recruiting NCT03121781 - Diaphragm Electrical Activity of Preterm Infants on nCPAP With Binasal Prongs Versus RAM Cannula N/A
Completed NCT02770976 - Respiratory Pattern During Neurally Adjusted Ventilator Assist (NAVA) in Preterm Infants N/A
Completed NCT01841268 - Skin Lipid Profiles in Term and Preterm Infants
Not yet recruiting NCT00320840 - Internal and Familial Resources and Motherhood. Follow Up of Mothers With Twins and Preterm Infants Versus Mothers With Single Full Term Infants N/A
Completed NCT00707837 - Nutritional Study in Preterm Infants Phase 3
Recruiting NCT03631264 - The Effect of Kinesiotaping Method on Feeding of Late Preterm Infants. N/A