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

Infant, Newborn, Diseases Clinical Trial

— glucose  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01514253
• Other study ID #: SAOR 006.CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: January 5, 2012
• Last updated: January 20, 2012
• Start date: February 2012
• Est. completion date: July 2012

Study information

• Verified date: January 2012
• Source: The Baruch Padeh Medical Center, Poriya
• Contact: Shay Barak, MD
• Phone: 04-6652328
• Email: sbarak[@]poria.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: July 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Days

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Caregiver, Investigator)

Related Conditions & MeSH terms

• Infant, Newborn, Diseases

Intervention

Drug:
• Glucose 25%
1 ml glucose 25%, once

Dietary Supplement:
• Materna RTF Stage 1
1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.

Other:
• Water for Injection
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination

Locations

Country	Name	City	State
Israel	NICU Department, The Baruch Padeh medical Center - Poriya	Tiberias

Sponsors (1)

Lead Sponsor	Collaborator
The Baruch Padeh Medical Center, Poriya

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	less discomfort	the infant will experience less pain during examination	immediate, during examination (day 1)	No