PainPhase 3NCT00713986

Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B

A Phase 3 study testing Water 2mL PO 2 minutes prior to intra-muscular injection, skin-to-skin contact and Glucose 25% 2 mL PO 2 minutes prior to injection in people with Pain and Analgesia, run by Federal University of São Paulo.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Acute procedural pain in neonates may be alleviated by non-pharmacological procedures. This study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to… Read more about this study

Who is it for?: Ages 12 to 72 hours
Conditions the study is for: Pain, Analgesia
What is being tested?: Water 2mL PO 2 minutes prior to intra-muscular injection, skin-to-skin contact and Glucose 25% 2 mL PO 2 minutes prior to injection
Type of treatment: Vaccines, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 640 participants
Where: No sites listed yet
Study dates: Mar 2006to Jul 2008
Phase: Phase 3
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 12 to 72 hours
All sexes
No healthy volunteers
Child

Who may be able to join

Written informed consent.
Gestational age of 37 0/7 to 41 6/7 weeks.
Patients cared in rooming-in, with post-natal age of 12 to 72 hours of life.
Adequate for gestational age and healthy infants.
No other painful stimuli before study except for Vitamine K injection soon after birth.
Interval from last feeding between 30 and 60 minutes.

Who cannot join

Mothers that used opioid at gestation labor or birth.
Delivery under general anesthesia.
Apgar score less than seven in the 1st or 5th minute of life.
Neonates that received any venous, arterial, capillary or spinal puncture.
Any congenital malformation or CNS abnormality.

About this study

Official title: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them

Conditions: Pain, Analgesia
Being tested: Water 2mL PO 2 minutes prior to intra-muscular injection, skin-to-skin contact, Glucose 25% 2 mL PO 2 minutes prior to injection, neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.
Keywords: Pain, Newborn Infant, Analgesia
Medical subject headings: Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Water 2mL PO 2 minutes prior to intra-muscular injectionProcedure or surgery
Sterile Water 2mL PO - single dose
skin-to-skin contactProcedure or surgery
neonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.
Glucose 25% 2 mL PO 2 minutes prior to injectionProcedure or surgery
Glucose 25% 2mL PO - single dose
neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.Procedure or surgery
neonates will receive 2 mL of glucose 25% PO (single dose) 2 minutes prior to the acute painful procedure. Skin-to-skin contact will start 2 minutes after the intra-muscular injection and will stop 2 minutes afterwards.

Study groups in NCT00713986
Study group	Role	What they receive
Noanalgesia	Sham comparator	Patients in this group wil receive 2 mL of water PO 2 minutes prior to vaccination, then they will rest in crib during cleansing of the right tigh, during injection of the right tigh for hepatitis B vaccination and 2 minutes after the injection. Infants will not receive any handling during the whole procedure outside the prespecified above. Receives: Procedure: Water 2mL PO 2 minutes prior to intra-muscular injection
Skin-to-skin	Experimental	Patients in this group wil receive 2mL of water 2 minutes prior vaccination and will be put on skin-to-skin contact with their mothers at the same time. After this time cleansing of the right tigh will be done followed by intra-muscular injection for hepatitis B vaccination. Patients will stay on skin-to-skin contact with their mothers for the following 2 minutes after injection. Infants will not receive any additional sensorial stimulation during the whole procedure outside the prespecified above. Receives: Procedure: skin-to-skin contact
Glucose	Experimental	Patients in this group wil receive 2mL of glucose 25% 2 minutes prior vaccination, then they will rest in crib during cleansing of the right tigh, during injection of the right tigh for hepatitis B vaccination and 2 minutes after the injection. Infants will not receive any handling during the whole procedure outside the prespecified above. Receives: Procedure: Glucose 25% 2 mL PO 2 minutes prior to injection
Skin&Glucose	Experimental	Patients in this group wil receive 2mL of glucose 25% PO 2 minutes prior vaccination and will be put on skin-to-skin contact with their mothers at the same time. After this time cleansing of the right tigh will be done followed by intra-muscular injection for hepatitis B vaccination. Patients will stay on skin-to-skin contact with their mothers for the following 2 minutes after injection. Infants will not receive any additional sensorial stimulation during the whole procedure outside the prespecified above. Receives: Procedure: neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.

What is being measured

The primary outcome is the main question the study is designed to answer.

Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)
Measured: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection

Secondary outcomes (1)

Physiologic pain assessment variables: heart rate and oxygen saturation
Measured: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Jul 2008

First posted14 Jul 2008 (estimated)
Study startMar 2006
Primary completionOct 2007
Study completionJul 2008

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 PainStudies 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 640 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00713986
Sponsor's protocol ID: ID: AGC 1107
Status last verified: Jul 2008
First submitted: 10 Jul 2008
Last updated: 14 Jul 2008
Results posted: No
Data monitoring committee: No

Publications

Chermont AG, Falcao LF, de Souza Silva EH, de Cassia Xavier Balda R, Guinsburg R. Skin-to-skin contact and/or oral 25% dextrose for procedural pain relief for term newborn infants. Pediatrics. 2009 Dec;124(6):e1101-7. doi: 10.1542/peds.2009-0993.
PubMed 19948613

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 14 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-Pharmacologic Interventions to Relief Pain in Healthy Newborns Submitted to Vaccination to Hepatitis B: a Comparison Between Skin-to-Skin Contact, Glucose 25% and Both of Them
ClinicalTrials.gov ID: NCT00713986
Acronym / sponsor ID: ID: AGC 1107
Conditions: Pain, Analgesia
Keywords: Pain, Newborn Infant, Analgesia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 640 participants (actual)
Lead sponsor: Federal University of São PauloUniversity, hospital or other
Study start: Mar 2006
Primary completion: Oct 2007 (actual)
Study completion: Jul 2008 (actual)
First posted: 14 Jul 2008 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Noanalgesia	Sham comparator	Procedure: Water 2mL PO 2 minutes prior to intra-muscular injectionPatients in this group wil receive 2 mL of water PO 2 minutes prior to vaccination, then they will rest in crib during cleansing of the right tigh, during injection of the right tigh for hepatitis B vaccination and 2 minutes after the injection. Infants will not receive any handling during the whole procedure outside the prespecified above.
Skin-to-skin	Experimental	Procedure: skin-to-skin contactPatients in this group wil receive 2mL of water 2 minutes prior vaccination and will be put on skin-to-skin contact with their mothers at the same time. After this time cleansing of the right tigh will be done followed by intra-muscular injection for hepatitis B vaccination. Patients will stay on skin-to-skin contact with their mothers for the following 2 minutes after injection. Infants will not receive any additional sensorial stimulation during the whole procedure outside the prespecified above.
Glucose	Experimental	Procedure: Glucose 25% 2 mL PO 2 minutes prior to injectionPatients in this group wil receive 2mL of glucose 25% 2 minutes prior vaccination, then they will rest in crib during cleansing of the right tigh, during injection of the right tigh for hepatitis B vaccination and 2 minutes after the injection. Infants will not receive any handling during the whole procedure outside the prespecified above.
Skin&Glucose	Experimental	Procedure: neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.Patients in this group wil receive 2mL of glucose 25% PO 2 minutes prior vaccination and will be put on skin-to-skin contact with their mothers at the same time. After this time cleansing of the right tigh will be done followed by intra-muscular injection for hepatitis B vaccination. Patients will stay on skin-to-skin contact with their mothers for the following 2 minutes after injection. Infants will not receive any additional sensorial stimulation during the whole procedure outside the prespecified above.

Who may qualify

Ages: 12 to 72 hours
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (6 listed)

Written informed consent.
Gestational age of 37 0/7 to 41 6/7 weeks.
Patients cared in rooming-in, with post-natal age of 12 to 72 hours of life.
Adequate for gestational age and healthy infants.
No other painful stimuli before study except for Vitamine K injection soon after birth.

Key exclusion criteria (5 listed)

Mothers that used opioid at gestation labor or birth.
Delivery under general anesthesia.
Apgar score less than seven in the 1st or 5th minute of life.
Neonates that received any venous, arterial, capillary or spinal puncture.
Any congenital malformation or CNS abnormality.

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
Water 2mL PO 2 minutes prior to intra-muscular injectionSterile Water 2mL PO - single dose	Procedure or surgery	Noanalgesia
skin-to-skin contactneonates will receive skin-to-skin contact beginning 2 minutes before the intra-muscular injection and stopping 2 minutes afterwards.	Procedure or surgery	Skin-to-skin
Glucose 25% 2 mL PO 2 minutes prior to injectionGlucose 25% 2mL PO - single dose	Procedure or surgery	Glucose
neonates will receive skin-to-skin contact beginning 2 minutes after the intra-muscular injection and stopping 2 minutes afterwards.neonates will receive 2 mL of glucose 25% PO (single dose) 2 minutes prior to the acute painful procedure. Skin-to-skin contact will start 2 minutes after the intra-muscular injection and will stop 2 minutes afterwards.	Procedure or surgery	Skin&Glucose

Primary outcome

Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP)
Time frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection

1 secondary outcome

Physiologic pain assessment variables: heart rate and oxygen saturation
Time frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection

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 14 Jul 2008.
Derived from this study: PubMed 19948613Chermont AG, Falcao LF, de Souza Silva EH, de Cassia Xavier Balda R, Guinsburg R. Skin-to-skin contact and/or oral 25% dextrose for procedural pain relief for term newborn infants. Pediatrics. 2009 Dec;124(6):e1101-7. doi: 10.1542/peds.2009-0993.

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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.

Aurimery G Chermont principal investigator

Federal University of Para and Federal University of São Paulo

Ruth Guinsburg study director

Federal University of São Paulo

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 5 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 14 Jul 2008. 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. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Neonatal pain scales: Neonatal infant pain Scale (NIPS), Neonatal Facial Coding System (NFCS) and Premature Infant Pain Profile (PIPP) (time frame: before the pain procedure (atrest), during cleaning of the region, at injection, and 2 minutes after injection). 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 NCT00713986, 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 14 Jul 2008.