InfantNCT01289808
Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
A study testing Glucose 25% in people with Infant and Newborn Diseases, run by The Baruch Padeh Medical Center, Poriya.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 16 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Newborn Diseases
- What is being tested?
- Glucose 25%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Feb 2011to Jul 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term above 37 weeks gestation.
- Normal birth-weight, healthy infants
- Males and Females
- Whose parents have signed the informed consent form
Who cannot join
- Premature born below 37 weeks
- Chromosomal abnormalities or congenital malformation.
- Suffering neurological imbalance
- Inability of oral feeding
About this study
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 for procedural pain on infant pain responses during a subsequent care giving procedure.
Read the detailed description
Pain in the newborn and young infant is a source of stress for the infant, family and care providers.
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. Our objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.
- Conditions
- Infant, Newborn Diseases
- Being tested
- Glucose 25%
- Keywords
- Glucose, analgesic, newborns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose 25%Drug
Also called Water for injection
1ml of glucose 25% once
Glucose 25%Drug
Also called water for injection once per os
1ml glucose once per os
| Study group | Role | What they receive |
|---|---|---|
| glucose 25% | Experimental | 180 healthy babies born term in the Baruch Padeh Medical Center, Poriya.
There will be three study groups:
Study Group: 60 newborn infants who will receive 1cc 25% Glucose, 2-3 minutes prior red-reflex examination.
Base line (control) Group 1: 60 newborn infants who will receive 1cc Water for Injection (WFI), 2-3 minutes prior red-reflex examination.
Base line (control ) Group 2: 60 newborn infants who will not receive neither glucose nor Water for Injection (WFI), 2-3 minutes prior red-reflex examination Receives: Drug: Glucose 25% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced infant response to a routine care procedure after glucose 25% analgesia
An observer nurse will focus on the infant's facial expression. A score between 0 and 3 will be assigned for each of the three facial expression indicators.
For physiological data, infants will be monitored for changes in heart rate and oxygen saturation using a transcutaneous pulse oximeter. A score between 0 and 3 will be assigned for each of the physiological indicators
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2011
- Study completionJul 2011
Why it stopped: changes were made to the which needed an entireley new submission
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Baruch Padeh Medical Center, Poriya
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Shay Barak, The Baruch Padeh Medical Center, Poriya
- Investigators
- Shay Barak, MD, Principal investigator, Neonatal Department, The Baruch Padeh Medical center - Poria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289808
- Sponsor's protocol ID
- SAOR 005.CTIL
- Status last verified
- Jan 2012
- First submitted
- 27 Jan 2011
- Last updated
- 9 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Infant Response To A Routine Care Procedure After Glucose 25% Analgesia
- ClinicalTrials.gov ID
- NCT01289808
- Acronym / sponsor ID
- SAOR 005.CTIL
- Conditions
- Infant, Newborn Diseases
- Keywords
- Glucose, analgesic, newborns
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: changes were made to the which needed an entireley new submission
- Enrolment
- 180 participants (actual)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Feb 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 for procedural pain on infant pain responses during a subsequent care giving procedure.
Detailed description
Pain in the newborn and young infant is a source of stress for the infant, family and care providers.
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. Our objective is to determine the effect of glucose 25% analgesia for procedural pain on infant pain responses during a subsequent care giving procedure.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glucose 25% | Experimental | Drug: Glucose 25%180 healthy babies born term in the Baruch Padeh Medical Center, Poriya. There will be three study groups: Study Group: 60 newborn infants who will receive 1cc 25% Glucose, 2-3 minutes prior red-reflex examination. Base line (control) Group 1: 60 newborn infants who will receive 1cc Water for Injection (WFI), 2-3 minutes prior red-reflex examination. Base line (control ) Group 2: 60 newborn infants who will not receive neither glucose nor Water for Injection (WFI), 2-3 minutes prior red-reflex examination |
Who may qualify
- Ages
- 1 day to 16 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Full term above 37 weeks gestation.
- Normal birth-weight, healthy infants
- Males and Females
- Whose parents have signed the informed consent form
Key exclusion criteria (4 listed)
- Premature born below 37 weeks
- Chromosomal abnormalities or congenital malformation.
- Suffering neurological imbalance
- Inability of oral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose 25%Also: Water for injection1ml of glucose 25% once | Drug | glucose 25% |
| Glucose 25%Also: water for injection once per os1ml glucose once per os | Drug | glucose 25% |
Primary outcome
Reduced infant response to a routine care procedure after glucose 25% analgesia
Time frame: 30 minutes
An observer nurse will focus on the infant's facial expression. A score between 0 and 3 will be assigned for each of the three facial expression indicators. For physiological data, infants will be monitored for changes in heart rate and oxygen saturation using a transcutaneous pulse oximeter. A score between 0 and 3 will be assigned for each of the physiological indicators
Results and safety
The study was stopped early (reason given: changes were made to the which needed an entireley new submission). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shay Barak, MD principal investigator
Neonatal Department, The Baruch Padeh Medical center - Poria
Questions about this trial
What is this clinical trial studying?
A study testing Glucose 25% in people with Infant and Newborn Diseases, run by The Baruch Padeh Medical Center, Poriya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: changes were made to the which needed an entireley new submission). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduced infant response to a routine care procedure after glucose 25% analgesia (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2012.