Preterm Birth ComplicationNCT05955404
Kangroo Mother Care
A study testing Kangaroo mother care in people with Preterm Birth Complication, run by University of Baghdad at 1 site in Iraq.
Trial summary
infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs. Read more about this study
- Who is it for?
- Ages 32 to 37 weeksHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth Complication
- What is being tested?
- Kangaroo mother care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteIraq
- Study dates
- 2 Nov 2022to 28 Feb 2023
- 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 32 to 37 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Preterm infants whose corrected gestational age from (32 - <37) weeks of pregnancy
- Preterm infants who do not experience any painful procedure for last 24 hours
- Preterm infants do not receive any sedation for last 24 hours
Who cannot join
- full-term infants whose corrected gestational age is >37 weeks
- extremely preterm (< 28 weeks)
- very preterm (28-<32 weeks)
- proven or suspected sepsis
- major congenital malformations
- all heart defect except neonatal Patent ductus arteriosus (PDA)
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- necrotizing enterocolitis
- neurodevelopmental disability
- who receive respiratory support {Mechanical Ventilation, Continuous Positive Airway Pressure, or high-flow support
- indicated for surgery
- contraindication to oral sucrose
- Twins
- infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Kangaroo Mother Care in Alleviating Preterm Infant's Pain
infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.
Read the detailed description
infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs and comparing the pain intensity with preterm infants who receive conventional care.
- Conditions
- Preterm Birth Complication
- Being tested
- Kangaroo mother care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo mother careOther
This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo mother care | Experimental | This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU. Receives: Other: Kangaroo mother care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Premature Infant Pain Profile-Revised (PIPP-R)
The Premature Infant Pain Profile-Revised (PIPP-R) measures the intensity of pain that the preterm infants experience in NICU through infant indicators (change in heart rate from baseline, decrease in oxygen saturation from baseline, browse bulge, eye squeeze, and naso-labial furrow. It also includes gestational age and behavioral state.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start2 Nov 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm Birth ComplicationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hiba Abdulwahid Dawood, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955404
- Sponsor's protocol ID
- kangroo mother care
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kangaroo Mother Care in Alleviating Preterm Infant's Pain
- ClinicalTrials.gov ID
- NCT05955404
- Acronym / sponsor ID
- kangroo mother care
- Conditions
- Preterm Birth Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 2 Nov 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 21 Jul 2023 (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.
infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs.
Detailed description
infants had a condition that might influence their responses to pain, e.g., congenital anomalies or severe illnesses requiring treatment with antiepileptics, muscle relaxants, or analgesic drugs and comparing the pain intensity with preterm infants who receive conventional care.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU.
| Arm | Type | Receives |
|---|---|---|
| Kangaroo mother care | Experimental | Other: Kangaroo mother careThis study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU. |
Who may qualify
- Ages
- 32 to 37 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants whose corrected gestational age from (32 - <37) weeks of pregnancy
- Preterm infants who do not experience any painful procedure for last 24 hours
- Preterm infants do not receive any sedation for last 24 hours
Key exclusion criteria (13 listed)
- full-term infants whose corrected gestational age is >37 weeks
- extremely preterm (< 28 weeks)
- very preterm (28-<32 weeks)
- proven or suspected sepsis
- major congenital malformations
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 |
|---|---|---|
| Kangaroo mother careThis study uses the Kangaroo mother care as a non-pharmacological strategy to alleviate the pain that preterm infants experience in the NICU. | Other | Kangaroo mother care |
Primary outcome
Premature Infant Pain Profile-Revised (PIPP-R)
Time frame: Two months
The Premature Infant Pain Profile-Revised (PIPP-R) measures the intensity of pain that the preterm infants experience in NICU through infant indicators (change in heart rate from baseline, decrease in oxygen saturation from baseline, browse bulge, eye squeeze, and naso-labial furrow. It also includes gestational age and behavioral state.
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 21 Jul 2023.
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The Goal is to Examine the Impact of Doula-delivered, Nurse-coordinated Postpartum Care Among Individuals With Preterm Births <34 Weeks' Gestation Requiring NICU Admission.
Doula Support, Postpartum
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo mother care in people with Preterm Birth Complication, run by University of Baghdad at 1 site in Iraq.
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 3 inclusion and 13 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 21 Jul 2023. 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 Iraq. 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. 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?
Premature Infant Pain Profile-Revised (PIPP-R) (time frame: Two months). 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 21 Jul 2023.