Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
Overview
- Phase
- Not Applicable
- Intervention
- Glucose 25%
- Conditions
- Infant, Newborn, Diseases
- Sponsor
- The Baruch Padeh Medical Center, Poriya
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- less discomfort
- Last Updated
- 14 years ago
Overview
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.
Investigators
Shay Barak
Senior Neonatologist, Neonatal Intensive Care
The Baruch Padeh Medical Center, Poriya
Eligibility 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
Arms & Interventions
glucose 25%
1 ml of glucose once
Intervention: Glucose 25%
infant formula
Materna RTF stage 1
Intervention: Materna RTF Stage 1
Water for Injection
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
Intervention: Water for Injection
Outcomes
Primary Outcomes
less discomfort
Time Frame: immediate, during examination (day 1)
the infant will experience less pain during examination