AnalgesiaNCT03389789
Newborn Cortical Response to Pain and Non Pharmacological Analgesia
A study testing Oral glucose solution + maternal holding, Breastfeeding and Oral glucose solution in people with Analgesia, run by IRCCS Burlo Garofolo.
Trial summary
Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. Read more about this study
- Who is it for?
- Ages 3 to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Oral glucose solution + maternal holding, Breastfeeding and Oral glucose solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2016to 31 May 2017
- 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 3 to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Full term healthy infants, needing a heel-prick for metabolic screening;
- Informed consent obtained from parents.
Who cannot join
- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
About this study
Official title: Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.
- Conditions
- Analgesia
- Being tested
- Oral glucose solution + maternal holding, Breastfeeding, Oral glucose solution, Oral expressed breastmilk
- Keywords
- pain, infant, near-infrared spectroscopy, non pharmacological analgesia
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose solution + maternal holdingOther
Infant will receive both the oral glucose solution and the contact with the mother
BreastfeedingOther
Infants will be breastfed
Oral glucose solutionOther
Infant will receive only oral glucose solution without contact with the mother
Oral expressed breastmilkOther
Infant will receive only oral expressed breast milk without contact with the mother
| Study group | Role | What they receive |
|---|---|---|
| Oral glucose solution + maternal holding | Experimental | Infants will receive 2 mL of oral glucose solution two minutes before the heel-prick and will be held in the mothers' lap (maternal relationship) throughout the painful procedure. Receives: Other: Oral glucose solution + maternal holding |
| Breastfeeding | Experimental | Infants will be breastfed two minutes before the heel-prick and throughout the painful procedure. Receives: Other: Breastfeeding |
| Oral glucose solution | Active comparator | Infants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table. Receives: Other: Oral glucose solution |
| Oral expressed breastmilk | Active comparator | Infants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table. Receives: Other: Oral expressed breastmilk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cortical oxy-haemoglobin increase
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)
Measured: During the procedure
Secondary outcomes (1)
Neonatal Infant Pain Scale (NIPS)
The NIPS assesses 5 behavioral factors (facial expression, cry, arms, legs, and state of arousal) and one physiological factor (breathing patterns), each of which contains two items that are assigned scores of 0 or 1 (except for the crying factor, which comprises three items and is scored on a scale of 0 to 2). The scale yields a total score ranging from 0 to 7, where scores more than 3 are indicative of pain.
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2018
- Study start2 Nov 2016
- Primary completion31 May 2017
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Barbone, Prof, Study chair, Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, ItalyStefano Bembich, MSC, Principal investigator, Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389789
- Sponsor's protocol ID
- RC 50/11
- Status last verified
- Oct 2018
- First submitted
- 27 Dec 2017
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bembich S, Cont G, Causin E, Paviotti G, Marzari P, Demarini S. Infant Analgesia With a Combination of Breast Milk, Glucose, or Maternal Holding. Pediatrics. 2018 Sep;142(3):e20173416. doi: 10.1542/peds.2017-3416.
PubMed 30166366
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Pain Processing in Full Term Infants, After Giving Different Non-pharmacological Analgesia
- ClinicalTrials.gov ID
- NCT03389789
- Acronym / sponsor ID
- RC 50/11
- Conditions
- Analgesia
- Keywords
- pain, infant, near-infrared spectroscopy, non pharmacological analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Study start
- 2 Nov 2016 (actual)
- Primary completion
- 31 May 2017 (actual)
- Study completion
- 31 May 2017 (actual)
- First posted
- 4 Jan 2018 (actual)
- 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.
Minor painful procedures are frequently performed on newborn infants and non-pharmacological analgesia is commonly used. As more than one analgesic method may be applied simultaneously in clinical practice, the relative contribution and efficacy of analgesic components still needs to be further elucidated. In the present study neonatal cortical brain response during four types of non-pharmacological analgesia (oral glucose, expressed breastmilk, maternal holding plus oral glucose, maternal holding plus breastfeeding) will be studied. The aim is to assess the differential effect of oral solutions (glucose, breastmilk), when given alone or in combination with maternal relationship (holding, breastfeeding). The study will test the hypothesis that the mother-infant relationship would improve the analgesic effect of oral solutions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oral glucose solution + maternal holding | Experimental | Other: Oral glucose solution + maternal holdingInfants will receive 2 mL of oral glucose solution two minutes before the heel-prick and will be held in the mothers' lap (maternal relationship) throughout the painful procedure. |
| Breastfeeding | Experimental | Other: BreastfeedingInfants will be breastfed two minutes before the heel-prick and throughout the painful procedure. |
| Oral glucose solution | Active comparator | Other: Oral glucose solutionInfants will receive 2 mL of oral glucose solution given two minutes before the heel-prick on a changing table. |
| Oral expressed breastmilk | Active comparator | Other: Oral expressed breastmilkInfants will receive 2 mL of expressed breastmilk given two minutes before the heel-prick on a changing table. |
Who may qualify
- Ages
- 3 to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Full term healthy infants, needing a heel-prick for metabolic screening;
- Informed consent obtained from parents.
Key exclusion criteria (1 listed)
- Presence of sedation or analgesia (other than non pharmacological analgesia given during the experimental procedure)
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 |
|---|---|---|
| Oral glucose solution + maternal holdingInfant will receive both the oral glucose solution and the contact with the mother | Other | Oral glucose solution + maternal holding |
| BreastfeedingInfants will be breastfed | Other | Breastfeeding |
| Oral glucose solutionInfant will receive only oral glucose solution without contact with the mother | Other | Oral glucose solution |
| Oral expressed breastmilkInfant will receive only oral expressed breast milk without contact with the mother | Other | Oral expressed breastmilk |
Primary outcome
Cortical oxy-haemoglobin increase
Time frame: During the procedure
Multichannel near-infrared spectroscopy will be used to estimate cerebral cortex activation by measuring increase in cortical oxy-haemoglobin (HbO2)
1 secondary outcome
Neonatal Infant Pain Scale (NIPS)
Time frame: During the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Background: PubMed 30166366Bembich S, Cont G, Causin E, Paviotti G, Marzari P, Demarini S. Infant Analgesia With a Combination of Breast Milk, Glucose, or Maternal Holding. Pediatrics. 2018 Sep;142(3):e20173416. doi: 10.1542/peds.2017-3416.
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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.
Fabio Barbone, Prof study chair
Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
Stefano Bembich, MSC principal investigator
Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose solution + maternal holding, Breastfeeding and Oral glucose solution in people with Analgesia, run by IRCCS Burlo Garofolo.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 3 Oct 2018. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cortical oxy-haemoglobin increase (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03389789, which also lists 1 linked publication.
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 3 Oct 2018.