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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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

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Infant, Newborn, Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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glucose 25%

1 ml of glucose once

Group Type EXPERIMENTAL

Glucose 25%

Intervention Type DRUG

1 ml glucose 25%, once

infant formula

Materna RTF stage 1

Group Type EXPERIMENTAL

Materna RTF Stage 1

Intervention Type DIETARY_SUPPLEMENT

1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.

Water for Injection

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

Group Type PLACEBO_COMPARATOR

Water for Injection

Intervention Type OTHER

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

Interventions

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Glucose 25%

1 ml glucose 25%, once

Intervention Type DRUG

Materna RTF Stage 1

1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.

Intervention Type DIETARY_SUPPLEMENT

Water for Injection

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

Intervention Type OTHER

Other Intervention Names

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Materna RTF Phase 1 WFI

Eligibility Criteria

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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

Minimum Eligible Age

1 Day

Maximum Eligible Age

16 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes