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

Baruch Padeh Medical Center

Status: Unknown

Conditions: Infant, Newborn, Diseases

Treatments: Other: Water for Injection; Dietary Supplement: Materna RTF Stage 1; Drug: Glucose 25%

Study type: Interventional

Funder types: Other

Identifiers

NCT01514253

SAOR 006.CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 1 to 16 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

180 participants in 3 patient groups, including a placebo group

glucose 25%

Experimental group

Description:

1 ml of glucose once

Treatment:

Drug: Glucose 25%

infant formula

Experimental group

Description:

Materna RTF stage 1

Treatment:

Dietary Supplement: Materna RTF Stage 1

Water for Injection

Placebo Comparator group

Description:

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

Treatment:

Other: Water for Injection