Premature InfantGuidelineNCT07052786
Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
A study testing Infants will receive group care based on individualized developmental care according to the guide. in people with Premature Infant and Clustered Care, run by KTO Karatay University at 1 site in Turkey (Türkiye).
Trial summary
The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Infant, Clustered Care, Neonatal Intensive Care Unit
- What is being tested?
- Infants will receive group care based on individualized developmental care according to the guide.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2025to 15 Jan 2026
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Working in the NICU of Necmettin Erbakan University Medical Faculty Hospital,
- Having at least 3 months of experience in the NICU,
- Volunteering to participate in the research.
Who cannot join
- The nurse wanting to leave the study during the study
- The nurse not participating in the training or not completing the training
- The nurse not being able to complete the study, including the final
Trial locations and contacts
1 site in 1 country.
About this study
The Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability. It supports the practice of clustered care, which refers to grouping routine medical and nursing procedures into a single care time period to reduce handling and allow the infant uninterrupted rest and maintenance of the sleep-wake cycle.
This study aims to develop a clustered care practice guideline and evaluate its effectiveness. The study was designed as a single-blind randomized controlled trial, where the participating nurses will not be informed about their group allocation (intervention or control) to reduce bias.The study will be conducted between July and September 2025 in the level 2 and 3 NICUs of Necmettin Erbakan University Faculty of Medicine Hospital in Konya, Turkey.
Read more
The study population includes all 44 nurses working in these NICUs who meet the inclusion criteria and agree to participate. Since the entire population is accessible, total population sampling will be used. After data collection is completed, a post hoc power analysis will be conducted using G*Power (v3.1.9.2).
Data will be collected using the "Descriptive Information Form for the Infant and the Nurse" and the "Clustered Care Practice Guideline". Pre-test data will be collected before training, and post-test data will be collected 4-6 weeks after the training.
The intervention group will receive the Clustered Care Practice Training Based on Individualized Developmental Care in two in-person sessions (approx. 45 minutes per session), delivered in small groups (11-12 participants). A training booklet prepared by the researchers will be distributed at the end of the sessions.
The normality of the data will be assessed using the Kolmogorov-Smirnov test, normal distribution curves, and skewness-kurtosis values. Parametric tests will be used for normally distributed data; non-parametric tests will be used otherwise. A significance level of P<0.05 will be applied.
Ethical approval was obtained from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research (decision no: 2022/014, date: 21.06.2022). Institutional permission was obtained from NEU Faculty of Medicine Hospital. Written informed consent will be obtained from all participating nurses and from parents of the observed infants.
Read the detailed description
Premature infants require intensive care during the early stages of life due to their physiological immaturity and heightened sensitivity to environmental stimuli. Routine care practices commonly performed in neonatal intensive care units (NICUs) may negatively affect the comfort and physiological stability of these infants. Therefore, individualized and developmentally supportive care practices tailored to the specific needs of premature infants have become essential.
This randomized controlled trial aims to evaluate the effectiveness of a clustered care practice guideline developed in accordance with individualized developmental care principles. The study will be conducted with nurses working in a neonatal intensive care unit. Nurses will be randomly assigned to either an intervention group or a control group.
The intervention group will receive training on the use of a clinical guideline designed to implement clustered care based on individualized developmental care, while the control group will continue to provide standard routine care. The effectiveness of the intervention will be assessed through the average scores obtained from the use of the guideline and a qualitative analysis of nurses' perspectives. This study is expected to highlight the importance of developmental care approaches in nursing and contribute to enhancing the overall quality of care provided in NICUs.
- Being tested
- Infants will receive group care based on individualized developmental care according to the guide., Standard care
- Keywords
- clustered care, guideline,nurse, NICU
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infants will receive group care based on individualized developmental care according to the guide.Behavioural
Also called Care based on guidelines
A guide to implementing group care based on individualized developmental care will be developed, and nurses working in the NICU will be trained in group care practices and how to use the guide.
Standard careBehavioural
Nurses working in the NICU will continue to provide standard care. After the study is completed, nurses in the control group will also receive the same training as the other group.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Individualized developmental care-based group care will be provided to infants according to the guidelines. Receives: Behavioral: Infants will receive group care based on individualized developmental care according to the guide. |
| Control group | Active comparator | Infants will receive routine care. Receives: Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurse behavior change
Measured by test score change from pre- to post-test within 6 weeks Research literature generally classifies observation methods into three types: participant observation, non-participant observation, and covert observation. In this study, a structured, direct, non-participant observation method was used to observe the care practices of nurses working in the neonatal intensive care unit in accordance with the developed Clustered Care Implementation Guide. Each nurse was observed twice during the designated care times-once during the pre-test and once during the post-test-with respect to the care practices they performed.
To minimize the risk of observer bias, the Clustered Care Implementation Guide was used as a structured observation form. The care stages were predefined according to the routine clinical workflow, and only the practices, behaviours, and responses that were actually observed were recorded in the guide; no subjective interpretations or comments were added. Throughout
Measured: within 6 weeks
Secondary outcomes (1)
Nurses' opinions on the effectiveness of the clinical guideline
Evaluation of nurses' perceptions regarding the effectiveness, applicability, and usability of the individualized developmental clustered care guideline.
The scoring is based on the 4-point Likert-type assessment section of the 55-item Clustered Care Implementation Guide. In the scoring process, the "performed" option is scored as 1, whereas the "not performed despite being required" option is scored as 0. The "not performed because it was not required" and "not applicable" options are marked during care provision but are excluded from the scoring. For example, if five items are marked as "not performed because it was not required" or "not applicable," the total score is calculated based on 50 rather than 55 items. If 48 of the remaining 50 items are scored as 1, the percentage of items marked as "performed" represents the score obtained from the guide.Since this is a clinical practice guide rather than a scale, no cut-off value has been established. A higher total score on the guide.
Measured: 4-6 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2025
- Study start1 Jul 2025
- Primary completion1 Nov 2025
- Study completion15 Jan 2026
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.
- 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
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- KTO Karatay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Tokan Özkılıçaslan, KTO Karatay University
- Investigators
- Emine Geçkil, MD, PhD, Study director, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07052786
- Sponsor's protocol ID
- 2022/014
- Acronym
- Guideline
- Status last verified
- Aug 2026
- First submitted
- 23 Jun 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
- ClinicalTrials.gov ID
- NCT07052786
- Acronym / sponsor ID
- Guideline / 2022/014
- Keywords
- clustered care, guideline,nurse, NICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- KTO Karatay UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 7 Jul 2025 (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 Individualized Developmental Care (IDC) model was developed to minimize the negative impact of the neonatal intensive care environment and to support infants' physiological stability. It supports the practice of clustered care, which refers to grouping routine medical and nursing procedures into a single care time period to reduce handling and allow the infant uninterrupted rest and maintenance of the sleep-wake cycle.
This study aims to develop a clustered care practice guideline and evaluate its effectiveness. The study was designed as a single-blind randomized controlled trial, where the participating nurses will not be informed about their group allocation (intervention or control) to reduce bias.The study will be conducted between July and September 2025 in the level 2 and 3 NICUs of Necmettin Erbakan University Faculty of Medicine Hospital in Konya, Turkey.
The study population includes all 44 nurses working in these NICUs who meet the inclusion criteria and agree to participate. Since the entire population is accessible, total population sampling will be used. After data collection is completed, a post hoc power analysis will be conducted using G*Power (v3.1.9.2).
Data will be collected using the "Descriptive Information Form for the Infant and the Nurse" and the "Clustered Care Practice Guideline". Pre-test data will be collected before training, and post-test data will be collected 4-6 weeks after the training.
The intervention group will receive the Clustered Care Practice Training Based on Individualized Developmental Care in two in-person sessions (approx. 45 minutes per session), delivered in small groups (11-12 participants). A training booklet prepared by the researchers will be distributed at the end of the sessions.
The normality of the data will be assessed using the Kolmogorov-Smirnov test, normal distribution curves, and skewness-kurtosis values. Parametric tests will be used for normally distributed data; non-parametric tests will be used otherwise. A significance level of P<0.05 will be applied.
Ethical approval was obtained from the Ethics Committee of KTO Karatay University Pharmaceutical and Medical Research (decision no: 2022/014, date: 21.06.2022). Institutional permission was obtained from NEU Faculty of Medicine Hospital. Written informed consent will be obtained from all participating nurses and from parents of the observed infants.
Detailed description
Premature infants require intensive care during the early stages of life due to their physiological immaturity and heightened sensitivity to environmental stimuli. Routine care practices commonly performed in neonatal intensive care units (NICUs) may negatively affect the comfort and physiological stability of these infants. Therefore, individualized and developmentally supportive care practices tailored to the specific needs of premature infants have become essential.
This randomized controlled trial aims to evaluate the effectiveness of a clustered care practice guideline developed in accordance with individualized developmental care principles. The study will be conducted with nurses working in a neonatal intensive care unit. Nurses will be randomly assigned to either an intervention group or a control group.
The intervention group will receive training on the use of a clinical guideline designed to implement clustered care based on individualized developmental care, while the control group will continue to provide standard routine care. The effectiveness of the intervention will be assessed through the average scores obtained from the use of the guideline and a qualitative analysis of nurses' perspectives. This study is expected to highlight the importance of developmental care approaches in nursing and contribute to enhancing the overall quality of care provided in NICUs.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Infants will receive group care based on individualized developmental care according to the guide.Individualized developmental care-based group care will be provided to infants according to the guidelines. |
| Control group | Active comparator | Behavioral: Standard careInfants will receive routine care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Working in the NICU of Necmettin Erbakan University Medical Faculty Hospital,
Key exclusion criteria (3 listed)
- The nurse wanting to leave the study during 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 |
|---|---|---|
| Infants will receive group care based on individualized developmental care according to the guide.Also: Care based on guidelinesA guide to implementing group care based on individualized developmental care will be developed, and nurses working in the NICU will be trained in group care practices and how to use the guide. | Behavioural | Experimental |
| Standard careNurses working in the NICU will continue to provide standard care. After the study is completed, nurses in the control group will also receive the same training as the other group. | Behavioural | Control group |
Primary outcome
Nurse behavior change
Time frame: within 6 weeks
Measured by test score change from pre- to post-test within 6 weeks Research literature generally classifies observation methods into three types: participant observation, non-participant observation, and covert observation. In this study, a structured, direct, non-participant observation method was used to observe the care practices of nurses working in the neonatal intensive care unit in accordance with the developed Clustered Care Implementation Guide. Each nurse was observed twice during the designated care times-once during the pre-test and once during the post-test-with respect to the care practices they performed. To minimize the risk of observer bias, the Clustered Care Implementation Guide was used as a structured observation form. The care stages were predefined according to the routine clinical workflow, and only the practices, behaviours, and responses that were actually observed were recorded in the guide; no subjective interpretations or comments were added. Throughout
1 secondary outcome
Nurses' opinions on the effectiveness of the clinical guideline
Time frame: 4-6 weeks post-intervention
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 19 Aug 2026.
- Individual participant dataSharing planned: No. Confidentiality
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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.
Emine Geçkil, MD, PhD study director
Necmettin Erbakan 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 Infants will receive group care based on individualized developmental care according to the guide. in people with Premature Infant and Clustered Care, run by KTO Karatay 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 3 inclusion and 3 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 19 Aug 2026. 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?
Nurse behavior change (time frame: within 6 weeks). 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 19 Aug 2026.