Infant, Newborn, DiseasesglucoseNCT01514253
Reduced Infant Response to a Routine Care Procedure After Glucose 25% Analgesia in Comparison to Materna RTF Stage 1
A study testing Glucose 25%, Materna RTF Stage 1 and Water for Injection in people with Infant, Newborn, Diseases, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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%, Materna RTF Stage 1 and Water for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2012to Jul 2012
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
NICU Department, The Baruch Padeh medical Center - Poriya
Tiberias
Shay Barak, MD, 04-6652328, sbarak@poria.health.gov.il
Amir Kushnir, MD
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 in comparison to Materna RTF Stage 1 for procedural pain on infant pain responses during a subsequent care giving procedure.
Read the 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.
- Conditions
- Infant, Newborn, Diseases
- Being tested
- Glucose 25%, Materna RTF Stage 1, Water for Injection
- Keywords
- glucose, analgesic, newborns
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose 25%Drug
1 ml glucose 25%, once
Materna RTF Stage 1Dietary supplement
Also called Materna RTF Phase 1
1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.
Water for InjectionOther
Also called WFI
1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
| Study group | Role | What they receive |
|---|---|---|
| glucose 25% | Experimental | 1 ml of glucose once Receives: Drug: Glucose 25% |
| infant formula | Experimental | Materna RTF stage 1 Receives: Dietary Supplement: Materna RTF Stage 1 |
| Water for Injection | Placebo comparator | 1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination Receives: Other: Water for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
less discomfort
the infant will experience less pain during examination
Measured: immediate, during examination (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Newborn, DiseasesStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 180 participants (estimated)
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, The Baruch Pade Medical Center - PoriyaAmir Kushnir, MD, Study director, The Baruch Padeh Medical Center - Poria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514253
- Sponsor's protocol ID
- SAOR 006.CTIL
- Acronym
- glucose
- Status last verified
- Jan 2012
- First submitted
- 5 Jan 2012
- Last updated
- 23 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 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 in Comparison to Materna RTF Stage 1
- ClinicalTrials.gov ID
- NCT01514253
- Acronym / sponsor ID
- glucose / SAOR 006.CTIL
- Conditions
- Infant, Newborn, Diseases
- Keywords
- glucose, analgesic, newborns
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- The Baruch Padeh Medical Center, PoriyaOther government
- Study start
- Feb 2012
- Primary completion
- May 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 23 Jan 2012 (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 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.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| glucose 25% | Experimental | Drug: Glucose 25%1 ml of glucose once |
| infant formula | Experimental | Dietary Supplement: Materna RTF Stage 1Materna RTF stage 1 |
| Water for Injection | Placebo comparator | Other: Water for Injection1 ml 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%1 ml glucose 25%, once | Drug | glucose 25% |
| Materna RTF Stage 1Also: Materna RTF Phase 11ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination. | Dietary supplement | infant formula |
| Water for InjectionAlso: WFI1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination | Other | Water for Injection |
Primary outcome
less discomfort
Time frame: immediate, during examination (day 1)
the infant will experience less pain during examination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2012.
Related trials for Infant, Newborn, Diseases
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
RecruitingObservational study
Registry of Ehlers-Danlos Syndrome
Ehlers-Danlos Syndrome
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
RecruitingPhase 2/3
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
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
The Baruch Pade Medical Center - Poriya
Amir Kushnir, MD study director
The Baruch Padeh Medical Center - Poria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glucose 25%, Materna RTF Stage 1 and Water for Injection in people with Infant, Newborn, Diseases, run by The Baruch Padeh Medical Center, Poriya at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 23 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shay Barak, MD (04-6652328, sbarak@poria.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
less discomfort (time frame: immediate, during examination (day 1)). 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 23 Jan 2012.