Transition Model-Based Discharge Training in Parents of Preterm Infants

NCT05525624 | Completed

• 1 other identifier: 0732
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Preterm Infant; Parents; Premature Birth; Randomized Controlled Trial; Transitional Care

Outcome Measures

Primary Outcomes (1)

• Effect of TRAMPRE

  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.

  Change from baseline effect of TRAMPRE at 3 months

Secondary Outcomes (2)

• Level of postpartum depression

  Change from baseline level of postpartum depression at 3 months

• Frequency of readmission

  Change from baseline Frequency of readmission at 3 months

Study Arms (2)

Experimental

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.

Device: TRAMPRE

Control Group

ACTIVE COMPARATOR

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.

Other: Control Group

Interventions

TRAMPRE DEVICE

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

Also known as: discharge interventions

Experimental

Control Group OTHER

routine neonatal clinic discharge training of the hospital

Also known as: routine neonatal clinic discharge training

Control Group

Eligibility Criteria

• Age: 15 Years - 49 Years
• Gender Eligibility Details: Mothers of preterm infants were included in the study because mothers are involved in primary infant care
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suleyman Demirel University: lead

Study Sites (2)

Suleyman Demirel University

Isparta, 32000, Turkey (Türkiye)

Location

Şerife Tutar

Isparta, 32000, Turkey (Türkiye)

Location

Related Publications (1)

• 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 Dec;48(6):692-705. doi: 10.1002/nur.70017. Epub 2025 Aug 23.

  PMID: 40847827 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Şerife Tutar

  Suleyman Demirel University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Şerife Tutar

Model Details: Transition Model is discharge model in preterm infants.

Study Record Dates

• First Submitted: February 27, 2022
• First Posted: September 1, 2022
• Study Start: January 5, 2021
• Primary Completion: June 30, 2022
• Study Completion: July 31, 2022
• Last Updated: September 1, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)