Premature InfantNCT05410639
Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
A study testing online education program and no online education program in people with Premature Infant, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level. Read more about this study
- Who is it for?
- Ages 0 to 8 monthsHealthy volunteers can take part
- Conditions the study is for
- Premature Infant
- What is being tested?
- online education program and no online education program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Feb 2021to 18 Mar 2022
- 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 0 to 8 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment.
- Being a premature baby born at or under 32 weeks
- infant corrected age between 0-8 months
- To agree to participate in the study.
Who cannot join
- Having a concomitant major anomaly and genetic disease
- The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.
Read the detailed description
Our study aim to increase the level f knowledge of the parents of premature infants that stayed in the NICU,to better manage their stress and to provide them with informations to support the motor and social-communication development of their infants.
- Conditions
- Premature Infant
- Being tested
- online education program, no online education program
- Keywords
- Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
online education programOther
The training we provided was to give exercises and advice to parents according to the age of the baby in order to stimulate the motor and social development of the baby,and then, an improvement in the stress state of the parents by their participation in the care of their baby.The training, which began with the discharge of the baby from the hospital, was in the form of slide presentations and videos.
no online education programOther
Parents and their infants in the control group did not receive any online education program
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Parents of premature infants in the experimental group received online education consist of information to support infants motor,social-communication development.and to manage the parents stress. Receives: Other: online education program |
| Control group | Placebo comparator | The parents of premature babies in the control group did not receive any education programs Receives: Other: no online education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alberta Infant Motor Scale (AIMS)
AIMS assesses the gross infant motor skills in supine, prone, sitting and standing positions with 58 items.the child is scored dec 0 to 58 points and evaluated with age-appropriate percentile curves:0-10 atypical development, 11-25 questionable performance, 26-75 normal performance, 76-90 very good performance, 91-100 are classified as excellent performance.
Measured: Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
The Social-Communication Area Screening Test of İnfant (SCASI)
SCASI assesses the social-communication infant skills,filled by the parents.it is an original and fast test for the early identification and evaluation of children at developmental risk in infancy and early childhood up to the age of 6-24 months.
Measured: Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.
Secondary outcomes (1)
Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
PSI-4-SF assesses the parents stress level.PSI-4-SF contains 36 items: 12 items for Parental Stress (PS) , 12 items for Parent-Child dysfonctional Interaction (P-CDI), and 12 items for Difficult Child (DC).The normal range for scores is within the 16th to 84th percentiles.Scores in the 85th to 89th percentile are considered high,and scores in the 90th percentile or higher are considered clinically significant.
Measured: Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start24 Feb 2021
- Primary completion17 Mar 2021
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khaoula Ben Kilani, Principal investigator, Bachelor study principal invistigator Marmara UniversityGönül Acar, Study chair, Assoc.Prof.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410639
- Sponsor's protocol ID
- 09.2020.1352
- Status last verified
- Dec 2021
- First submitted
- 5 Jun 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Online Education Given to Parent on Motor Social Development for The Premature Babies in The Neonatal Intensive Care Unites
- ClinicalTrials.gov ID
- NCT05410639
- Acronym / sponsor ID
- 09.2020.1352
- Conditions
- Premature Infant
- Keywords
- Premature Infant,Motor Development,Social-Communication Development,Parental Stress,Online Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 24 Feb 2021 (actual)
- Primary completion
- 17 Mar 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 8 Jun 2022 (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.
Our study aim to evaluate the effect of online program that provides education to parents of premature infants in which stayed in the neonatal intensive care units (NICU),in their motor,socail-communişcation development and the parents stress level.
Detailed description
Our study aim to increase the level f knowledge of the parents of premature infants that stayed in the NICU,to better manage their stress and to provide them with informations to support the motor and social-communication development of their infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Other: online education programParents of premature infants in the experimental group received online education consist of information to support infants motor,social-communication development.and to manage the parents stress. |
| Control group | Placebo comparator | Other: no online education programThe parents of premature babies in the control group did not receive any education programs |
Who may qualify
- Ages
- 0 to 8 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- infants Stayed in the neonatal intensive care unit for some time after premature birth for the purpose of care and treatment.
- Being a premature baby born at or under 32 weeks
- infant corrected age between 0-8 months
- To agree to participate in the study.
Key exclusion criteria (2 listed)
- Having a concomitant major anomaly and genetic disease
- The fact that the family did not accept the evaluation of their baby in motor and social-communication area at sixth month of the study.
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 |
|---|---|---|
| online education programThe training we provided was to give exercises and advice to parents according to the age of the baby in order to stimulate the motor and social development of the baby,and then, an improvement in the stress state of the parents by their participation in the care of their baby.The training, which began with the discharge of the baby from the hospital, was in the form of slide presentations and videos. | Other | Study group |
| no online education programParents and their infants in the control group did not receive any online education program | Other | Control group |
Primary outcome
Alberta Infant Motor Scale (AIMS)
Time frame: Premature infant motor development was assessed one time by AIMS at their 6 month corrected age
AIMS assesses the gross infant motor skills in supine, prone, sitting and standing positions with 58 items.the child is scored dec 0 to 58 points and evaluated with age-appropriate percentile curves:0-10 atypical development, 11-25 questionable performance, 26-75 normal performance, 76-90 very good performance, 91-100 are classified as excellent performance.
The Social-Communication Area Screening Test of İnfant (SCASI)
Time frame: Premature infant social-communication development was assessed one time by SCASI at their 6 month corrected age.
SCASI assesses the social-communication infant skills,filled by the parents.it is an original and fast test for the early identification and evaluation of children at developmental risk in infancy and early childhood up to the age of 6-24 months.
1 secondary outcome
Parenting Stress Index, Fourth Edition Short Form (PSI-4-SF)
Time frame: Parents stress level was assessed one time by PSI-4-SF at their infant 6 month corrected age.
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 8 Jun 2022.
Related trials for Premature Infant
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
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.
Khaoula Ben Kilani principal investigator
Bachelor study principal invistigator Marmara University
Gönül Acar study chair
Assoc.Prof.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing online education program and no online education program in people with Premature Infant, run by Marmara University at 1 site in Turkey (Türkiye).
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 2 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 8 Jun 2022. 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 Turkey (Türkiye). 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?
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?
Alberta Infant Motor Scale (AIMS) (time frame: Premature infant motor development was assessed one time by AIMS at their 6 month corrected age). 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 8 Jun 2022.