Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
glucose
1 other identifier
interventional
180
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 5, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedJanuary 23, 2012
January 1, 2012
3 months
January 5, 2012
January 20, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
less discomfort
the infant will experience less pain during examination
immediate, during examination (day 1)
Study Arms (3)
glucose 25%
EXPERIMENTAL1 ml of glucose once
infant formula
EXPERIMENTALMaterna RTF stage 1
Water for Injection
PLACEBO COMPARATOR1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
Interventions
1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
Eligibility Criteria
You may qualify if:
- Full term above 37 weeks gestation.
- Normal birth-weight, healthy infants
- Males and Females
- Whose parents have signed the informed consent form
You may not qualify if:
- Premature born below 37 weeks
- Chromosomal abnormalities or congenital malformation.
- Suffering neurological imbalance
- Inability of oral feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NICU Department, The Baruch Padeh medical Center - Poriya
Tiberias, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shay Barak, MD
The Baruch Pade Medical Center - Poriya
- STUDY DIRECTOR
Amir Kushnir, MD
The Baruch Padeh Medical Center - Poria
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Neonatologist, Neonatal Intensive Care
Study Record Dates
First Submitted
January 5, 2012
First Posted
January 23, 2012
Study Start
February 1, 2012
Primary Completion
May 1, 2012
Study Completion
July 1, 2012
Last Updated
January 23, 2012
Record last verified: 2012-01