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

This study has been terminated.
(changes were made to the which needed an entireley new submission)
Sponsor:
Information provided by (Responsible Party):
Shay Barak, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier:
NCT01289808
First received: January 27, 2011
Last updated: January 6, 2012
Last verified: January 2012
  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 for procedural pain on infant pain responses during a subsequent care giving procedure.


Condition Intervention
Infant
Newborn Diseases
Drug: Glucose 25%

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reduced infant response to a routine care procedure after glucose 25% analgesia [ Time Frame: 30 minutes ] [ Designated as safety issue: No ]

    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



Enrollment: 180
Study Start Date: February 2011
Study Completion Date: July 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 injection
Drug: Glucose 25%
1ml glucose once per os
Other Name: water for injection once per os

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.

  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: NCT01289808

Sponsors and Collaborators
The Baruch Padeh Medical Center, Poriya
Investigators
Principal Investigator: Shay Barak, MD Neonatal Department, The Baruch Padeh Medical center - Poria
  More Information

No publications provided

Responsible Party: Shay Barak, Senior Neonatologist, The Baruch Padeh Medical Center, Poriya
ClinicalTrials.gov Identifier: NCT01289808     History of Changes
Other Study ID Numbers: SAOR 005.CTIL
Study First Received: January 27, 2011
Last Updated: January 6, 2012
Health Authority: Israel: Ethics Commission

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

ClinicalTrials.gov processed this record on April 16, 2014