Neonatal NeurobehaviorNCT03740594
Effect of KMC on Neurobehavior of Preterm Neonates
A study testing KMC in people with Neonatal Neurobehavior, run by Ain Shams University.
Trial summary
This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Neonatal Neurobehavior
- What is being tested?
- KMC
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 1 Feb 2018
- 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 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Stable preterm neonates with gestational age between 31 and 35 weeks.
Who cannot join
- Neonates with major congenital birth defects or chromosomal anomalies.
- Perinatal asphyxia and intra-ventricular hemorrhage.
- Hemodynamically significant cardiac abnormalities.
- Neonates received postnatal steroids.
- Neonates whose mothers had a history of drug abuse during pregnancy.
About this study
Official title: Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates
This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.
- Conditions
- Neonatal Neurobehavior
- Being tested
- KMC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KMCBehavioural
Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.
| Study group | Role | What they receive |
|---|---|---|
| KMC 60 min group | Active comparator | Not described Receives: Behavioral: KMC |
| KMC 120 min group | Active comparator | Not described Receives: Behavioral: KMC |
| control group | Active comparator | Not described Receives: Behavioral: KMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9.
Measured: the age of 36 weeks
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9. For stress, lethargy, non-optimal response and asymmetic reflexes, the higher the seb-scale, the worse. In other sub-scales, the higher the scale, the better.
Measured: the age of 36 weeks
Secondary outcomes (1)
Salivary cortisol
measuring salivary cortisol
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start1 Aug 2016
- Primary completion1 Dec 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal NeurobehaviorStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Mohamed Mohamed Shinkar, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740594
- Sponsor's protocol ID
- Effect of KMC on neurobehavior
- Status last verified
- Nov 2018
- First submitted
- 10 Nov 2018
- Last updated
- 15 Nov 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Kangaroo Mother Care and Its Duration on Neurobehavioral Performance and Stress Response of Preterm Neonates
- ClinicalTrials.gov ID
- NCT03740594
- Acronym / sponsor ID
- Effect of KMC on neurobehavior
- Conditions
- Neonatal Neurobehavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 14 Nov 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.
This prospective cohort study was conducted on stable preterm infants (31 to 35 weeks gestation). Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. Neonates were evaluated by Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) at 36 weeks gestation. Salivary cortisol was measured before and after first KMC session and after 7 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| KMC 60 min group | Active comparator | Behavioral: KMC |
| KMC 120 min group | Active comparator | Behavioral: KMC |
| control group | Active comparator | Behavioral: KMC |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Stable preterm neonates with gestational age between 31 and 35 weeks.
Key exclusion criteria (5 listed)
- Neonates with major congenital birth defects or chromosomal anomalies.
- Perinatal asphyxia and intra-ventricular hemorrhage.
- Hemodynamically significant cardiac abnormalities.
- Neonates received postnatal steroids.
- Neonates whose mothers had a history of drug abuse during pregnancy.
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 |
|---|---|---|
| KMCNeonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days. | Behavioural | KMC 120 min group, KMC 60 min group, control group |
Primary outcome
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Time frame: the age of 36 weeks
applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9.
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS)
Time frame: the age of 36 weeks
applying Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) which is used to assess the neuro-behavioral performance of neonates.It consists of 13 subscales :Habituation, Attention, Arousal, Regulation, Handling procedures, Quality of movement, Excitability, Lethargy, Non-optimal reflexes, Asymmetric reflexes, Hypertonicity, and Stress/abstinence scale.Scores of subscales are from 1 to 9. For stress, lethargy, non-optimal response and asymmetic reflexes, the higher the seb-scale, the worse. In other sub-scales, the higher the scale, the better.
1 secondary outcome
Salivary cortisol
Time frame: 7 days
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 15 Nov 2018.
- Individual participant dataSharing planned: No
Related trials for Neonatal Neurobehavior
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Active, not recruitingEarly Phase 1
Neonatal Neurobehavioral And Motor Behavior In Ultra Early Physical Therapy Intervention
Neonatal Disease, Parenting
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.
Questions about this trial
What is this clinical trial studying?
A study testing KMC in people with Neonatal Neurobehavior, run by Ain Shams University.
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 1 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 15 Nov 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?
Neonatal Intensive Care Unit Network Neurobehavioral Scale (NNNS) (time frame: the age of 36 weeks). The study lists 2 primary outcomes in all. 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 15 Nov 2018.