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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01514253

Acronym

glucose

Enrollment

180

Registered

2012-01-23

Start date

2012-02-29

Completion date

2012-07-31

Last updated

2012-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infant, Newborn, Diseases

Keywords

glucose, analgesic, newborns

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.

Interventions

DRUGGlucose 25%

1 ml glucose 25%, once

DIETARY_SUPPLEMENTMaterna RTF Stage 1

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

OTHERWater for Injection

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Days to 16 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
less discomfort	immediate, during examination (day 1)	the infant will experience less pain during examination

Countries

Israel

Contacts

Primary ContactShay Barak, MD

sbarak@poria.health.gov.il04-6652328

Backup ContactRobyn Rubin, Coordinator

rrubin@poria.health.gov.il04-6652328

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026