Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
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|ClinicalTrials.gov Identifier: NCT01289808|
Recruitment Status : Terminated (changes were made to the which needed an entireley new submission)
First Posted : February 4, 2011
Last Update Posted : January 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Infant Newborn Diseases||Drug: Glucose 25%||Not Applicable|
Pain in the newborn and young infant is a source of stress for the infant, family and care providers.
During hospitalization, a neonate undergoes a number of necessary procedures that may be either painful or cause discomfort to the baby.
Pain experienced during the neonatal period is known to have long term effects on the baby.
The red-reflex test is a routine examination performed on a neonate after birth and once again before discharge from the hospital. The examination causes discomfort to the infant.
Glucose has analgesic and calming effects in newborns. To date, it is not known whether the beneficial effects extend to care giving procedures that are performed after painful procedures. Our objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||180 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Care Provider, Investigator)|
|Official Title:||Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||July 2011|
Experimental: glucose 25%
180 healthy babies born term in the Baruch Padeh Medical Center, Poriya.
There will be three study groups:
Study Group: 60 newborn infants who will receive 1cc 25% Glucose, 2-3 minutes prior red-reflex examination.
Base line (control) Group 1: 60 newborn infants who will receive 1cc Water for Injection (WFI), 2-3 minutes prior red-reflex examination.
Base line (control ) Group 2: 60 newborn infants who will not receive neither glucose nor Water for Injection (WFI), 2-3 minutes prior red-reflex examination
Drug: Glucose 25%
1ml of glucose 25% once
Other Name: Water for injectionDrug: Glucose 25%
1ml glucose once per os
Other Name: water for injection once per os
- Reduced infant response to a routine care procedure after glucose 25% analgesia [ Time Frame: 30 minutes ]
An observer nurse will focus on the infant's facial expression. A score between 0 and 3 will be assigned for each of the three facial expression indicators.
For physiological data, infants will be monitored for changes in heart rate and oxygen saturation using a transcutaneous pulse oximeter. A score between 0 and 3 will be assigned for each of the physiological indicators
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01289808
|Principal Investigator:||Shay Barak, MD||Neonatal Department, The Baruch Padeh Medical center - Poria|