Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia

January 6, 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 for procedural pain on infant pain responses during a subsequent care giving procedure.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

180

Phase

  • Not Applicable

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

No

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Water for injection
Drug: Glucose 25%
1ml glucose once per os
Other Names:
  • water for injection once per os

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 minutes

Collaborators and Investigators

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

Sponsor

The Baruch Padeh Medical Center, Poriya

Investigators

  • Principal Investigator: Shay Barak, MD, Neonatal Department, 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, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

January 27, 2011

First Submitted That Met QC Criteria

February 3, 2011

First Posted (Estimate)

February 4, 2011

Study Record Updates

Last Update Posted (Estimate)

January 9, 2012

Last Update Submitted That Met QC Criteria

January 6, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SAOR 005.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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