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Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1 (glucose)

This study is not yet open for participant recruitment.
Verified January 2012 by The Baruch Padeh Medical Center, Poriya
Sponsor:
Information provided by (Responsible Party):
Shay Barak, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01514253
First received: January 5, 2012
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention
Infant, Newborn, Diseases
 Drug: Glucose 25%
Dietary Supplement: Materna RTF Stage 1
Other: Water for Injection

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Official Title: Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by The Baruch Padeh Medical Center, Poriya:

Primary Outcome Measures:
  • less discomfort [ Time Frame: immediate, during examination (day 1) ] [ Designated as safety issue: No ]
    the infant will experience less pain during examination


Estimated Enrollment: 180
Study Start Date: February 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: glucose 25%
1 ml of glucose once
 Drug: Glucose 25%
1 ml glucose 25%, once
Experimental: infant formula
Materna RTF stage 1
 Dietary Supplement: Materna RTF Stage 1
1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.
Other Name: Materna RTF Phase 1
Placebo Comparator: Water for Injection
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
 Other: Water for Injection
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
Other Name: WFI

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.

  Eligibility

Ages Eligible for Study:   up to 16 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01514253

Contacts
Contact: Shay Barak, MD 04-6652328 sbarak@poria.health.gov.il
Contact: Robyn Rubin, Coordinator 04-6652328 rrubin@poria.health.gov.il

Locations
Israel
NICU Department, The Baruch Padeh medical Center - Poriya Not yet recruiting
Tiberias, Israel
Contact: Shay Barak, MD     04-6652328     sbarak@poria.health.gov.il    
Sub-Investigator: Amir Kushnir, MD            
Principal Investigator: Shay Barak, MD            
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            
Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Principal Investigator: Shay Barak, MD The Baruch Pade Medical Center - Poriya
Study Director: Amir Kushnir, MD The Baruch Padeh Medical Center - Poria
  More Information

No publications provided

Responsible Party: Shay Barak, Senior Neonatologist, Neonatal Intensive Care, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT01514253     History of Changes
Other Study ID Numbers: SAOR 006.CTIL
Study First Received: January 5, 2012
Last Updated: January 20, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by The Baruch Padeh Medical Center, Poriya:
glucose
analgesic
newborns

Additional relevant MeSH terms:
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013