Clustered care guideline for individualized developmental care in premature infants
Development and Effectiveness Evaluation of a Clustered Care Guideline Within Individualized Developmental Care: RCT
NA · KTO Karatay University · NCT07052786
This project will test whether training NICU nurses to group routine care into fewer handling sessions helps premature infants rest better and stay more physiologically stable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Sex | Female |
| Sponsor | KTO Karatay University (other) |
| Locations | 1 site (Konya) |
| Trial ID | NCT07052786 on ClinicalTrials.gov |
What this trial studies
This single-blind randomized controlled trial will randomize the 44 eligible NICU nurses at Necmettin Erbakan University to either receive training and a clinical guideline for clustered care based on individualized developmental care or to continue standard routine care. Nurses in the intervention group will be trained to group routine procedures into single care periods to minimize handling and support infants' sleep–wake cycles. Effectiveness will be measured using average scores from the guideline's use and a qualitative analysis of nurses' perspectives, and infant physiological stability and rest will be monitored as clinical outcomes. The study will be conducted in level 2 and 3 NICUs at Meram Faculty of Medicine in Konya, Turkey between July and September 2025.
Who should consider this trial
Good fit: Premature infants cared for in the participating level 2 or 3 NICUs whose bedside nurses are enrolled in the study are the intended beneficiaries of the intervention.
Not a fit: Infants requiring continuous hands-on or emergent care, or those not cared for by participating nurses, are unlikely to receive benefit from the clustered care intervention.
Why it matters
Potential benefit: If successful, the guideline could reduce unnecessary handling, improve infant sleep and physiological stability, and standardize nursing practice in the NICU.
How similar studies have performed: Previous research on developmental care and clustered care has reported improvements in infant stability and sleep, although nurse-training programs using a formal guideline in this exact format are less commonly tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Konya
- Meram Faculty of Medicine — Konya, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Fatma Tokan Özkılıçaslan, MSc
- Email: tokanftm@gmail.com
- Phone: +905396997157
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Premature Infant, Clustered Care, Neonatal Intensive Care Unit, Developmental Care, clustered care, guideline,nurse, NICU