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

January 20, 2012 updated by: Shay Barak, The Baruch Padeh Medical Center, Poriya
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 Overview

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

Interventional

Enrollment (Anticipated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Tiberias, Israel
        • NICU Department, The Baruch Padeh medical Center - Poriya
        • Contact:
        • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 2 weeks (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Materna RTF Phase 1
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:
  • WFI

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

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

May 1, 2012

Study Completion (Anticipated)

July 1, 2012

Study Registration Dates

First Submitted

January 5, 2012

First Submitted That Met QC Criteria

January 20, 2012

First Posted (Estimate)

January 23, 2012

Study Record Updates

Last Update Posted (Estimate)

January 23, 2012

Last Update Submitted That Met QC Criteria

January 20, 2012

Last Verified

January 1, 2012

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.

Clinical Trials on Infant, Newborn, Diseases

Clinical Trials on Glucose 25%

3
Subscribe