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

Study 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.

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

Conditions
-----------------
Infant, Newborn, Diseases

Intervention / Treatment
-----------------
* Drug: Glucose 25%
* Dietary Supplement: Materna RTF Stage 1
* Other: Water for Injection


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glucose 25%<br>1 ml of glucose once | Drug: Glucose 25%<br>* 1 ml glucose 25%, once<br>|
| Experimental: infant formula<br>Materna RTF stage 1 | Dietary Supplement: Materna RTF Stage 1<br>* 1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.<br>* Other names: Materna RTF Phase 1;|
| Placebo Comparator: Water for Injection<br>1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination | Other: Water for Injection<br>* 1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination<br>* Other names: WFI;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| less discomfort | the infant will experience less pain during examination | immediate, during examination (day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glucose, analgesic, newborns