Preterm InfantTRAMPRENCT05525624
Transition Model-Based Discharge Training in Parents of Preterm Infants
A study testing TRAMPRE in people with Preterm Infant and Parents, run by Suleyman Demirel University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Infant, Parents, Premature Birth
- What is being tested?
- TRAMPRE
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 5 Jan 2021to 31 Jul 2022
- 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 15 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Suleyman Demirel University
Isparta, 32000
Şerife Tutar
Isparta, 32000
About this study
Official title: Evaluation of the Effectiveness of Transition Model-Based Discharge Training in Parents of Preterm Infants:Double Blinded A Randomized Controlled Study
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
Read the 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.
- Being tested
- TRAMPRE, Control Group
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRAMPREDevice
Also called discharge interventions
discharge interventions Transition Model is discharge interventions in parents of preterm infants.
Control GroupOther
Also called routine neonatal clinic discharge training
routine neonatal clinic discharge training of the hospital
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline effect of TRAMPRE at 3 months
Secondary outcomes (2)
Level of postpartum depression
The Edinburgh Postpartum Depression Scale will be administered three months after discharge.
Measured: Change from baseline level of postpartum depression at 3 months
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.
Measured: Change from baseline Frequency of readmission at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start5 Jan 2021
- Primary completion30 Jun 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preterm 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
- Model description
- Transition Model is discharge model in preterm infants.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serife Tutar, Suleyman Demirel University
- Investigators
- Şerife Tutar, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525624
- Sponsor's protocol ID
- 0732
- Acronym
- TRAMPRE
- Status last verified
- Apr 2022
- First submitted
- 27 Feb 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40847827
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Transition Model-Based Discharge Training in Parents of Preterm Infants:Double Blinded A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05525624
- Acronym / sponsor ID
- TRAMPRE / 0732
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 5 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 1 Sep 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Transition Model is discharge model in preterm infants.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: TRAMPRETRAMPRE 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. |
| Control Group | Active comparator | Other: Control GroupParticipants 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. |
Who may qualify
- Ages
- 15 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- For mothers;
- For babies;
Key exclusion criteria (5 listed)
- For mothers;
- Having a physical or mental chronic illness that may affect the baby's care process
- For babies;
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 |
|---|---|---|
| TRAMPREAlso: discharge interventionsdischarge interventions Transition Model is discharge interventions in parents of preterm infants. | Device | Experimental |
| Control GroupAlso: routine neonatal clinic discharge trainingroutine neonatal clinic discharge training of the hospital | Other | Control Group |
Primary outcome
Effect of TRAMPRE
Time frame: Change from baseline effect of TRAMPRE at 3 months
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.
2 secondary outcomes
Level of postpartum depression
Time frame: Change from baseline level of postpartum depression at 3 months
Frequency of readmission
Time frame: Change from baseline Frequency of readmission at 3 months
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 1 Sep 2022.
- Derived from this study: PubMed 40847827Tutar 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.
- Individual participant dataSharing planned: No
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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.
Şerife Tutar principal investigator
Suleyman Demirel University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRAMPRE in people with Preterm Infant and Parents, run by Suleyman Demirel University at 2 sites 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 9 inclusion and 5 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 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Effect of TRAMPRE (time frame: Change from baseline effect of TRAMPRE at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05525624, which also lists 1 linked publication.
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 1 Sep 2022.