Transition Model-Based Discharge Training in Parents of Preterm Infants

NCT ID: NCT05525624

Last Updated: 2022-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-05

Study Completion Date

2022-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Infant and Child Monitoring Protocol prepared by the General Directorate of Mother and Child Health and Family Planning of the Ministry of Health regarding the monitoring of postpartum processes in our country. However, there is no separate recommendation for home follow-up and care of mothers and babies who gave birth preterm. In addition, there are deficiencies in the effective conduct of home visits specified in these guides. In addition to the parents' lack of knowledge about the long-term follow-up and care of these babies, the coordination between primary and secondary health care providers and senior health care providers is not at the desired level. In addition to all these, services such as training and consultancy cannot be carried out due to disruptions in many polyclinic services due to the COVID-19 pandemic worldwide. For this reason, there is a need to develop programs for home care and follow-up of preterm infants, who are a sensitive population, in terms of both reducing the patient density in hospitals and reducing the hospital return rates of preterm infants. In this context, the aim of our research is; The aim of this study is to evaluate the effectiveness of discharge training based on the Transition Model in parents with preterm infants.H1: In the group in which the interventions based on the Transition Model are applied, the information needs of the parents will be met more compared to the control group. H1: Parent-infant role development will be higher in the group in which interventions based on the Transition Model are applied. H1: The level of coping with stress will be better in the group in which interventions based on the Transition Model are applied. H1: The level of grief will be lower in the group in which interventions based on the Transition Model are applied. H1: The level of postpartum depression will be lower in the group in which interventions based on the Transition Model are applied. H1: Babies in the group in which interventions based on the Transition Model are applied will have fewer hospital admissions, except for the planned outpatient visit

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Intervention Group: The intervention protocol of the research will be based on the Transition Model. Discharge training will be applied to the participants in line with the "Preterm Baby Care Guide" at the discharge stage. Weekly telephone follow-up will be carried out for 12 weeks after discharge. Applications to be made to the initiative group are given below. Phone Follow-up/Interview: During the first 12 weeks following the discharge of the preterm baby, parents will be interviewed by phone at least once a week. During the interview, issues concerning the baby's health status (baby bed, physical conditions of the house, newborn jaundice, nutrition, etc.) will be included in the scope of the interview and suggestions will be made for the baby's growth and development in healthy conditions (safe sleep, clothing selection, etc.). Interviews will be held in line with the "Baby Care Skill Form" and each interview will be recorded in the form. The duration and number of interviews will be determined according to the needs of the parent. In addition, in this process, information such as which health institution application has been made, the degree of the institution applied (primary / secondary / tertiary health institution) will be recorded. Control Group: Participants in this group will be included in the routine neonatal clinic discharge training of the hospital where the research was conducted and no intervention will be applied. The Parents and Preterm Baby General Information Form will be applied to the parents who agreed to participate in the study at the first interview, and when the data collection process of the research is completed, these parents will be contacted by phone and the Transition Scale and Edinburgh Postnatal Depression Scale will be applied. As in the intervention group, information such as the status of application to the health institution, the reason for the application and the degree of the institution applied to (primary / secondary / tertiary health institution) will be recorded in this group. Statistical Package of Social Science (SPSS 23) package program will be used in the evaluation of the data obtained from the research. For the intervention and control groups, the Cronbach Alpha coefficient, scale score average and minimum-maximum values will be calculated for the pre-test and post-test. In order to compare the pre-test and post-test data of the intervention and control groups, the t-test for the difference of the mean of the two peer groups (t-test of two paired groups), the Wilcoxon Signed Ranks Test, and the Wilcoxon Signed Ranks Test, and the Mann Whitney-U Test for the data without normal distribution will be performed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Preterm Infant Parents Premature Birth Randomized Controlled Trial Transitional Care

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Transition Model is discharge model in preterm infants.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
The research will be conducted in a double-blind design and the data of the research will be collected by the clinical nurse. Parents participating in the research will not know that they are in the intervention or control group. Telephone support during the research process will be provided by an independent interviewer.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Experimental

TRAMPRE is an acronym that defines multimodal interventions discharge training. TRAMPRE will be applied to the participants in line with the "Preterm Baby Care Guide" at the discharge stage. Weekly telephone follow-up will be carried out for 12 weeks after discharge. Applications to be made to the initiative group are given below. Phone Follow-up/Interview: During the first 12 weeks following the discharge of the preterm baby, parents will be interviewed by phone at least once a week.

Group Type EXPERIMENTAL

TRAMPRE

Intervention Type DEVICE

discharge interventions Transition Model is discharge interventions in parents of preterm infants.

Control Group

Participants in this group will be included in the routine neonatal clinic discharge training of the hospital where the research was conducted and no intervention will be applied.

Group Type ACTIVE_COMPARATOR

Control Group

Intervention Type OTHER

routine neonatal clinic discharge training of the hospital

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TRAMPRE

discharge interventions Transition Model is discharge interventions in parents of preterm infants.

Intervention Type DEVICE

Control Group

routine neonatal clinic discharge training of the hospital

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

discharge interventions routine neonatal clinic discharge training

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* For mothers;

* Having given birth between 340/7-366/7 weeks
* Absence of a chronic disease that may affect physical and mental care
* Residing within the provincial borders of Antalya
* For babies;

* No congenital anomalies
* Postpartum neonatal asphyxia, respiratory distress syndrome, intraventricular hemorrhage and necrotizing enterocolitis etc. no problem
* Postpartum Apgar score \>7 Babies discharged after being followed up in
* The neonatal clinic will be included in the study

Exclusion Criteria

* For mothers;

\*Having a physical or mental chronic illness that may affect the baby's care process
* For babies;

* Neonatal asphyxia, respiratory distress syndrome, intraventricular hemorrhage and necrotizing enterocolitis etc. receiving ventilator support after delivery.
* Babies with a problem will not be included in the study.
Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Suleyman Demirel University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Serife Tutar

Dr.Şerife Tutar

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Şerife Tutar

Role: PRINCIPAL_INVESTIGATOR

Suleyman Demirel University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Suleyman Demirel University

Isparta, , Turkey (Türkiye)

Site Status

Şerife Tutar

Isparta, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

Tutar S, Demir Avci Y, Gozum S. The Effect of Transition Model-Based Discharge Training for Mothers of Late Preterm Infants (TRAMPRE): A Randomized Controlled Study. Res Nurs Health. 2025 Aug 23. doi: 10.1002/nur.70017. Online ahead of print.

Reference Type DERIVED
PMID: 40847827 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0732

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Warmed Blood Transfusion in Premature Infants
NCT06425783 ACTIVE_NOT_RECRUITING NA
Feeding Maturity in Preterm Infants
NCT07273266 RECRUITING NA