search
Back to results

Transition Model-Based Discharge Training in Parents of Preterm Infants (TRAMPRE)

Primary Purpose

Preterm Infant, Parents, Premature Birth

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
TRAMPRE
Control Group
Sponsored by
Suleyman Demirel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Preterm Infant

Eligibility Criteria

15 Years - 49 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Suleyman Demirel University
  • Şerife Tutar

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Level of postpartum depression
The Edinburgh Postpartum Depression Scale will be administered three months after discharge.
Frequency of readmission
Planned/unplanned admission to hospital after discharge:It is planned to be used in weekly planned parent interviews after discharge. The content of the form includes questions about hospital applications after discharge and the reasons for application.

Full Information

First Posted
February 27, 2022
Last Updated
August 31, 2022
Sponsor
Suleyman Demirel University
search

1. Study Identification

Unique Protocol Identification Number
NCT05525624
Brief Title
Transition Model-Based Discharge Training in Parents of Preterm Infants
Acronym
TRAMPRE
Official Title
Evaluation of the Effectiveness of Transition Model-Based Discharge Training in Parents of Preterm Infants:Double Blinded A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 5, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Suleyman Demirel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preterm Infant, Parents, Premature Birth, Randomized Controlled Trial, Transitional Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Transition Model is discharge model in preterm infants.
Masking
InvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
TRAMPRE
Other Intervention Name(s)
discharge interventions
Intervention Description
discharge interventions Transition Model is discharge interventions in parents of preterm infants.
Intervention Type
Other
Intervention Name(s)
Control Group
Other Intervention Name(s)
routine neonatal clinic discharge training
Intervention Description
routine neonatal clinic discharge training of the hospital
Primary Outcome Measure Information:
Title
Effect of TRAMPRE
Description
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.
Time Frame
Change from baseline effect of TRAMPRE at 3 months
Secondary Outcome Measure Information:
Title
Level of postpartum depression
Description
The Edinburgh Postpartum Depression Scale will be administered three months after discharge.
Time Frame
Change from baseline level of postpartum depression at 3 months
Title
Frequency of readmission
Description
Planned/unplanned admission to hospital after discharge:It is planned to be used in weekly planned parent interviews after discharge. The content of the form includes questions about hospital applications after discharge and the reasons for application.
Time Frame
Change from baseline Frequency of readmission at 3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Mothers of preterm infants were included in the study because mothers are involved in primary infant care
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Şerife Tutar
Organizational Affiliation
Suleyman Demirel University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suleyman Demirel University
City
Isparta
ZIP/Postal Code
32000
Country
Turkey
Facility Name
Şerife Tutar
City
Isparta
ZIP/Postal Code
32000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transition Model-Based Discharge Training in Parents of Preterm Infants

We'll reach out to this number within 24 hrs