- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01514253
Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1 (glucose)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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. The investigators objective is to determine the effect of glucose 25% analgesia in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Shay Barak, MD
- Phone Number: 04-6652328
- Email: sbarak@poria.health.gov.il
Study Contact Backup
- Name: Robyn Rubin, Coordinator
- Phone Number: 04-6652328
- Email: rrubin@poria.health.gov.il
Study Locations
-
-
-
Tiberias, Israel
- NICU Department, The Baruch Padeh medical Center - Poriya
-
Contact:
- Shay Barak, MD
- Phone Number: 04-6652328
- Email: sbarak@poria.health.gov.il
-
Sub-Investigator:
- Elena Chulsky, MD
-
Sub-Investigator:
- Tatiana Dolgunova, MD
-
Sub-Investigator:
- Natali Nikolski, MD
-
Sub-Investigator:
- Natali Shaykevich, MD
-
Sub-Investigator:
- Orly Benor, RN,BSN.MsN
-
Sub-Investigator:
- Gilat Yeganeh, LLB,LLM, RN
-
Sub-Investigator:
- Maryanne Nabso, RN,MA
-
Sub-Investigator:
- Sijal Hlehel, RN,MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Full term above 37 weeks gestation.
- Normal birth-weight, healthy infants
- Males and Females
- Whose parents have signed the informed consent form
Exclusion Criteria:
- Premature born below 37 weeks
- Chromosomal abnormalities or congenital malformation.
- Suffering neurological imbalance
- Inability of oral feeding
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: glucose 25%
1 ml of glucose once
|
1 ml glucose 25%, once
|
Experimental: infant formula
Materna RTF stage 1
|
1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.
Other Names:
|
Placebo Comparator: Water for Injection
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
|
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
less discomfort
Time Frame: immediate, during examination (day 1)
|
the infant will experience less pain during examination
|
immediate, during examination (day 1)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Shay Barak, MD, The Baruch Pade Medical Center - Poriya
- Study Director: Amir Kushnir, MD, The Baruch Padeh Medical Center - Poria
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SAOR 006.CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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