NCT01514253

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: The Baruch Padeh Medical Center, Poriya · Other Government
• Sex: All
• Age: 1 Day – 16 Days
• Healthy volunteers: Accepted

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.

Conditions

• Infant, Newborn, Diseases

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-05-01
• Completion: 2012-07-01
• First posted: 2012-01-23
• Last updated: 2012-01-23

Locations

1 site across 1 country: Israel