Infant DevelopmentNCT06144450
Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
A study testing Web-Based Monitoring Program in people with Infant Development and Maternal Stress, run by Gazi University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress, preparation for discharge, home care and problem-solving care skills. Read more about this study
- Who is it for?
- Ages 28 to 32 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Development, Maternal Stress, Growth
- What is being tested?
- Web-Based Monitoring Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2023to 1 Dec 2024
- 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 28 to 32 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- For mothers
- Those over 18 years of age,
- Literate,
- Having a computer or mobile phone,
- Having access to internet connection,
- Able to use the Internet,
Show all 15Show fewer
- Able to speak Turkish,
- Primiparous,
- Mothers who agree to participate in the study will be included in the study.
- For babies
- 28-316. born during the week of pregnancy,
- Birth weight 1000-2000 grams. the one which,
- Hospitalized for at least 5 days,
- Prematurity and related health problems (respiratory distress syndrome, intra cranial hemorrhage, patent ductus arteriosus, intrauterine growth retardation, small for gestational age, SEPSIS, retinopathy of prematurity, cholestasis, nutritional intolerance)
- Babies without congenital anomalies will be included in the study.
Who cannot join
- Mothers with physical and/or mental disabilities,
- Mothers diagnosed with a psychological disease (severe depression, suicide attempt, etc.),
- Mothers who are addicted to alcohol and substances,
- Mothers who cannot complete the modules will not be included in the research.
Trial locations and contacts
1 site in 1 country.
About this study
The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress, preparation for discharge, home care and problem-solving care skills. The population of the study will consist of mothers of premature infants receiving care and treatment in the neonatal intensive care units where the study is planned to be conducted between December 15, 2023 and December 01, 2024. Because no similar study was found in the literature, the sample calculation was performed using the G*power 3.1.9.2 program with effect size = 0.40, type 1 error = 0.05, and 95% power. The analysis yielded a sample size of 52, and considering a 20% loss rate, the total sample size was determined to be 62. Premature infants and their mothers sampled in the study will be assigned to the intervention and control groups by randomization with the stratified block method according to the gestation week, gender and birth weight of the infants. Block randomization will be done by creating 6 blocks consisting of 4 letters. Block randomization will be done by an academic independent of the research. The group with which the study will start will be determined by lottery by the independent academic and the participants will be assigned to the intervention and control groups with randomization envelopes. Mother Descriptive Information Form, Infant Descriptive Information and Follow-up Form, Preparation for Discharge from the Neonatal Intensive Care Unit and Home Care Scale, Neonatal Intensive Care Unit Parental Stress Scale, Problem Solving Skills Assessment Form, Ankara Developmental Screening Inventory, and Process Evaluation Form will be used for data collection. The research will be carried out in three stages; (1) creating the content of the follow-up program, (2) designing the web page, (3) implementing the program with mothers. The implementation of the program based on the Empowerment Model will be implemented in 3 stages: preparation of the premature infant hospitalized in the neonatal intensive care unit for discharge from the hospital, transition to home and home care.
Read the detailed description
Premature infants' hospital, home transition, and home care needs differ from those of other infants. After being discharged from the neonatal intensive care unit, mothers become the primary caregivers for their premature infants at home. Therefore, discharge preparation should begin when the infant is admitted to the hospital, continue throughout the neonatal intensive care unit stay, and be supported by home follow-up. It has been observed that mothers who have not adequately prepared for discharge often find themselves unprepared for their infants' discharge from the hospital and for providing adequate care at home Nurses provide discharge preparation to facilitate the mother's preparation for discharge, the mother and infant's transition to home, and home care. This preparation can support the mother's stress level and problem-solving skills, as well as the infant's physiological stability and age-appropriate growth and development. Supporting and empowering mothers of premature infants while their infants are in the neonatal intensive care unit is a critical nursing intervention. Therefore, neonatal intensive care unit nurses can use the Family-Centered Empowerment Model to empower mothers. The Family-Centered Empowerment Model has been shown to increase parenting responsibility, care skills, parental self-efficacy, self-, quality of life, and emotional regulation, and to decrease the burden of care in mothers of sick children through integrated programs. The use of technology in healthcare makes information more accessible.
- Conditions
- Infant Development, Maternal Stress, Growth
- Being tested
- Web-Based Monitoring Program
- Keywords
- premature infant, mother, discharge, transition to home, home care, nurse
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web-Based Monitoring ProgramOther
The research will be carried out in three stages; (1) creating the content of the follow-up program, (2) designing the web page, (3) implementing the program with mothers. The topics to be included in the monitoring program will be prepared within the framework of the "Empowerment Model". Knowledge and attitude-self-efficacy will be tried to be increased with the modules to be prepared. Accordingly, the program is planned to consist of 3 modules. These are "Preparation for Hospital Discharge Module", "Transitional Care Module" and "Home Care Module". The presented modules will be made accessible to mothers in the experimental group through a website. The modules will be completed in order and the necessary forms and follow-ups will be completed at the end of each module.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The presented modules will be made accessible to mothers in the experimental group through a website. The modules will be completed in order and the necessary forms and follow-ups will be completed at the end of each module. Receives: Other: Web-Based Monitoring Program |
| Control Group | No intervention | No intervention will be made in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baby Monitoring Form -1
Growth-development parameters of birth, discharge and home care (Height - meters)
Measured: at birth, 1st month, 3rd month
Neonatal Intensive Care Unit Parental Stress Scale
Scale; The sub-dimensions are Babies' Appearance and Behavior, Sights and Sounds, Your Relationship with Your Baby, and Your Role as a Parent.
Measured: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month. (Increase and decrease over time will be evaluated.)
Problem Solving Skills Evaluation Form
Subscales of the form are Child (Baby) Care Skill Subscale, Scanning Subscale, Formulation Subscale, Pre-evaluation (Prediction) Subscale, Planning Subscale, Application Subscale, Evaluation Subscale, Problem Solving Process Subscale.The lowest score that can be obtained from the entire scale is 27 and the highest score is 261.As the score increases, mothers' problem-solving skills increase.
Measured: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Preparation for Discharge from Neonatal Intensive Care Unit and Home Care Scale
The scale developed for mothers includes 4 sub-dimensions (feeding, general condition perception, hygienic care, care practices). A minimum of 22 and a maximum of 154 points can be obtained from the mother scale. High scores indicate that parents are ready for discharge.
Measured: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Process Evaluation Form
9 open-ended questions are asked about the benefits of the program, satisfaction levels with the program, the effects of the program on the feeling of knowledge and competence in baby care, the conveniences and difficulties of the program, and suggestions for the program.This form is a form in which qualitative and quantitative data are collected. Therefore, it has no upper and lower scores.
Measured: through discharge, an average of 3 month
Ankara Developmental Screening Inventory
It is a screening inventory that provides in-depth and systematic information about the development of babies and children (0 -6 years old).The inventory consists of 4 subdomains: language-cognitive, fine motor, gross motor and social skills-self-care.
Measured: through discharge, an average of 1 month; through discharge, an average of 3 month
Baby Monitoring Form -2
receiving emergency healthcare services after discharge (rate)
Measured: at birth, 1st month, 3rd month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start15 Dec 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant DevelopmentStudies of the same condition, open and under way.
- More trials run by Gazi 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rukiye Çelik, Gazi University
- Investigators
- Rukiye Çelik, Principal investigator, Gazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06144450
- Sponsor's protocol ID
- 2022-439
- Status last verified
- Aug 2025
- First submitted
- 1 Nov 2023
- Last updated
- 8 Aug 2025
- 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 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness of the Web-Based Monitoring Program Given to Mothers of Premature Babies
- ClinicalTrials.gov ID
- NCT06144450
- Acronym / sponsor ID
- 2022-439
- Conditions
- Infant Development, Maternal Stress, Growth
- Keywords
- premature infant, mother, discharge, transition to home, home care, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Gazi UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 22 Nov 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.
The study was planned to determine the effect of the web-based hospital and home follow-up program given to mothers of premature infants on infant growth-development, repeated hospitalization of the infant, maternal stress, preparation for discharge, home care and problem-solving care skills. The population of the study will consist of mothers of premature infants receiving care and treatment in the neonatal intensive care units where the study is planned to be conducted between December 15, 2023 and December 01, 2024. Because no similar study was found in the literature, the sample calculation was performed using the G*power 3.1.9.2 program with effect size = 0.40, type 1 error = 0.05, and 95% power. The analysis yielded a sample size of 52, and considering a 20% loss rate, the total sample size was determined to be 62. Premature infants and their mothers sampled in the study will be assigned to the intervention and control groups by randomization with the stratified block method according to the gestation week, gender and birth weight of the infants. Block randomization will be done by creating 6 blocks consisting of 4 letters. Block randomization will be done by an academic independent of the research. The group with which the study will start will be determined by lottery by the independent academic and the participants will be assigned to the intervention and control groups with randomization envelopes. Mother Descriptive Information Form, Infant Descriptive Information and Follow-up Form, Preparation for Discharge from the Neonatal Intensive Care Unit and Home Care Scale, Neonatal Intensive Care Unit Parental Stress Scale, Problem Solving Skills Assessment Form, Ankara Developmental Screening Inventory, and Process Evaluation Form will be used for data collection. The research will be carried out in three stages; (1) creating the content of the follow-up program, (2) designing the web page, (3) implementing the program with mothers. The implementation of the program based on the Empowerment Model will be implemented in 3 stages: preparation of the premature infant hospitalized in the neonatal intensive care unit for discharge from the hospital, transition to home and home care.
Detailed description
Premature infants' hospital, home transition, and home care needs differ from those of other infants. After being discharged from the neonatal intensive care unit, mothers become the primary caregivers for their premature infants at home. Therefore, discharge preparation should begin when the infant is admitted to the hospital, continue throughout the neonatal intensive care unit stay, and be supported by home follow-up. It has been observed that mothers who have not adequately prepared for discharge often find themselves unprepared for their infants' discharge from the hospital and for providing adequate care at home Nurses provide discharge preparation to facilitate the mother's preparation for discharge, the mother and infant's transition to home, and home care. This preparation can support the mother's stress level and problem-solving skills, as well as the infant's physiological stability and age-appropriate growth and development. Supporting and empowering mothers of premature infants while their infants are in the neonatal intensive care unit is a critical nursing intervention. Therefore, neonatal intensive care unit nurses can use the Family-Centered Empowerment Model to empower mothers. The Family-Centered Empowerment Model has been shown to increase parenting responsibility, care skills, parental self-efficacy, self-, quality of life, and emotional regulation, and to decrease the burden of care in mothers of sick children through integrated programs. The use of technology in healthcare makes information more accessible.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Web-Based Monitoring ProgramThe presented modules will be made accessible to mothers in the experimental group through a website. The modules will be completed in order and the necessary forms and follow-ups will be completed at the end of each module. |
| Control Group | No intervention | –No intervention will be made in the control group. |
Who may qualify
- Ages
- 28 to 32 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- For mothers
- For babies
Key exclusion criteria (4 listed)
- Mothers with physical and/or mental disabilities,
- Mothers diagnosed with a psychological disease (severe depression, suicide attempt, etc.),
- Mothers who are addicted to alcohol and substances,
- Mothers who cannot complete the modules will not be included in the research.
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 |
|---|---|---|
| Web-Based Monitoring ProgramThe research will be carried out in three stages; (1) creating the content of the follow-up program, (2) designing the web page, (3) implementing the program with mothers. The topics to be included in the monitoring program will be prepared within the framework of the "Empowerment Model". Knowledge and attitude-self-efficacy will be tried to be increased with the modules to be prepared. Accordingly, the program is planned to consist of 3 modules. These are "Preparation for Hospital Discharge Module", "Transitional Care Module" and "Home Care Module". The presented modules will be made accessible to mothers in the experimental group through a website. The modules will be completed in order and the necessary forms and follow-ups will be completed at the end of each module. | Other | Intervention Group |
Primary outcome
Baby Monitoring Form -1
Time frame: at birth, 1st month, 3rd month
Growth-development parameters of birth, discharge and home care (Height - meters)
Neonatal Intensive Care Unit Parental Stress Scale
Time frame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month. (Increase and decrease over time will be evaluated.)
Scale; The sub-dimensions are Babies' Appearance and Behavior, Sights and Sounds, Your Relationship with Your Baby, and Your Role as a Parent.
Problem Solving Skills Evaluation Form
Time frame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
Subscales of the form are Child (Baby) Care Skill Subscale, Scanning Subscale, Formulation Subscale, Pre-evaluation (Prediction) Subscale, Planning Subscale, Application Subscale, Evaluation Subscale, Problem Solving Process Subscale.The lowest score that can be obtained from the entire scale is 27 and the highest score is 261.As the score increases, mothers' problem-solving skills increase.
Preparation for Discharge from Neonatal Intensive Care Unit and Home Care Scale
Time frame: at birth; through birth, an average of 3 months; through discharge, an average of 3 day; through discharge, an average of 3 month
The scale developed for mothers includes 4 sub-dimensions (feeding, general condition perception, hygienic care, care practices). A minimum of 22 and a maximum of 154 points can be obtained from the mother scale. High scores indicate that parents are ready for discharge.
Process Evaluation Form
Time frame: through discharge, an average of 3 month
9 open-ended questions are asked about the benefits of the program, satisfaction levels with the program, the effects of the program on the feeling of knowledge and competence in baby care, the conveniences and difficulties of the program, and suggestions for the program.This form is a form in which qualitative and quantitative data are collected. Therefore, it has no upper and lower scores.
Ankara Developmental Screening Inventory
Time frame: through discharge, an average of 1 month; through discharge, an average of 3 month
It is a screening inventory that provides in-depth and systematic information about the development of babies and children (0 -6 years old).The inventory consists of 4 subdomains: language-cognitive, fine motor, gross motor and social skills-self-care.
Baby Monitoring Form -2
Time frame: at birth, 1st month, 3rd month
receiving emergency healthcare services after discharge (rate)
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 Aug 2025.
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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.
Rukiye Çelik principal investigator
Gazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Web-Based Monitoring Program in people with Infant Development and Maternal Stress, run by Gazi 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 15 inclusion and 4 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 Aug 2025. 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. 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?
Baby Monitoring Form -1 (time frame: at birth, 1st month, 3rd month). The study lists 7 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 Aug 2025.