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

Not Applicable

• Conditions: Infant, Newborn, Diseases
• Interventions: Drug: Glucose 25%; Other: Water for Injection; Dietary Supplement: Materna RTF Stage 1

• Registration Number: NCT01514253
• Lead Sponsor: The Baruch Padeh Medical Center, Poriya

Brief 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.

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 Timeline

• Status Verified: 2012-01
• Study First Submitted: 2012-01-05
• Study First Submitted QC: 2012-01-20
• Last Update Submitted: 2012-01-20
• Study First Posted: 2012-01-23
• Last Update Posted: 2012-01-23
• Study Start: 2012-02
• Primary Completion: 2012-05
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
glucose 25%	Glucose 25%	1 ml of glucose once
Water for Injection	Water for Injection	1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
infant formula	Materna RTF Stage 1	Materna RTF stage 1

Primary Outcome Measures

Name	Time	Method
less discomfort	immediate, during examination (day 1)	the infant will experience less pain during examination

Trial Locations

Locations (1)

NICU Department, The Baruch Padeh medical Center - Poriya; 🇮🇱 Tiberias, Israel