Lower Respiratory Tract InfectionNCT07183553
The Effect of a Family-Centered Care Approach on Infants Receiving High-Flow Nasal Oxygen Therapy
An observational study of Lower Respiratory Tract Infection, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
This research is an experimental study of randomized control with pre-test - post-test control group. The aim of this study is to determine the effect of family-centered care approach on physiological parameters and follow-up time in infants with respiratory failure diagnosed with lower respiratory tract infection and… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Lower Respiratory Tract Infection
- What is being tested?
- maintenance training
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2024to 8 Jul 2025
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: The study included babies and their mothers who were treated in baby wards and received high-flow nasal oxygen therapy.
Who may be able to join
- 18 years of age or older,
- Literate,
- Agreeing to participate in the study,
- Oriented to person, place, and time,
- No visual (except for those with improved vision using visual aids) or auditory communication difficulties (except for those with improved hearing using hearing aids) that would prevent them from understanding and expressing the information provided,
- No speech impairments/communication problems,
- Mothers of infants aged 28 days to 2 years, receiving high-flow oxygen therapy due to a lower respiratory tract infection, and without any chronic disease.
Who cannot join
- Mothers who did not speak or read Turkish,
- who were participating in a different study conducted at the clinic, were not included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Family-Centered Care Approach On Physiological Parameters And Follow-Up Tıme In Infants Receiving Hıgh-Flow Nasal Oxygen Therapy Wıth The Diagnosis Of Lower Respiratory Tract Infection
This research is an experimental study of randomized control with pre-test - post-test control group.
The aim of this study is to determine the effect of family-centered care approach on physiological parameters and follow-up time in infants with respiratory failure diagnosed with lower respiratory tract infection and receiving high-current oxygen therapy
Read the detailed description
The population of the study consisted of babies and their mothers who were receiving high-flow nasal oxygen therapy in the baby wards of Ankara Etlik City Hospital between December 2024 and March 2025.After receiving written consents with the volunteer consent form from the mothers who agreed to participate in the study, the volunteers were divided into intervention and control groups using the "computerized randomization method" (www.randomizer.org ). Patients were distributed to two groups according to the randomization list and all groups were informed about how to fill out follow-up forms. In both groups, the data in the section on introductory characteristics of the mother and baby in the first part of the Mother and Baby Introductory Information Form were filled in. A pre-test was administered with the family-centered care scale. The data related to the measurements of life signs (body temperature, pulse, respiration, oxygen saturation and blood pressure) contained in the introductory characteristics section of the baby were obtained from the patient's file and recorded. The intervention group received the "Family-Centered Care Program" and the control group received the standard care program of the clinic.The families in the intervention group were given training and information about family-centered care and were given an educational booklet that had been prepared. Before discharge, a post-test was conducted on both groups using the family-centered care scale.
- Conditions
- Lower Respiratory Tract Infection
- Being tested
- maintenance training
- Keywords
- Family-centered care, high-flow nasal oxygen therapy, lower respiratory tract infection, respiratory failure, nursing, infant
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
maintenance trainingOther
information has been provided in accordance with the content of the training booklet.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | After completing the data in the first section of the Mother and Baby Introductory Information Form, which includes information about the mother and baby, and the Family-Centered Care Scale, the mothers received one-on-one information, which lasted approximately 30 minutes, based on the content of the prepared education booklet. The education booklet covered topics on family-centered care, clinical equipment, steam application, and postural drainage. The mother was supported by a nurse throughout the care process until discharge. Maternal care practices were implemented under the supervision of the nurse, and questions about care were answered. The Family-Centered Care Scale was administered before discharge. Receives: Other: maintenance training | |
| control group | After completing the data in the first section of the Mother and Baby Information Form, which includes information about the mother and baby, and the Family-Centered Care Scale, the mothers were trained by the nurses in accordance with the standard training content of the service. This content included general service rules, general materials used in the service, and a service introduction. Families were also provided with basic information about high nasal flow, including what it means. Care practices were implemented by the nurse until discharge. The Family-Centered Care Scale was administered at discharge. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Family Centred Care Scale
The Family-Centered Care Scale (FCCS), consists of two sections. Both sections contain the same questions. The scale, divided into two sections for importance and consistency, consists of seven items. Each item is scored from 1 to 5. The lowest possible score is 7, and the highest is 35. As the total score increases, satisfaction with family-centered care increases in direct proportion to the score obtained from the scale. The items consist of questions regarding the evaluation of the nursing care received by parents during their hospital stay. The importance section evaluates the level of care shown by the nurses, and the consistency section evaluates the level of care shown by the nurses in the child's care. In the scale's evaluation, the importance and consistency scores are added together to form a single score.
Measured: three days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Dec 2024
- Primary completion1 Mar 2025
- Study completion8 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, RUMEYSA NUR YILMAZ, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183553
- Sponsor's protocol ID
- HITU-SBF-RNY-01
- Status last verified
- Sep 2025
- First submitted
- 9 Jul 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Family-Centered Care Approach On Physiological Parameters And Follow-Up Tıme In Infants Receiving Hıgh-Flow Nasal Oxygen Therapy Wıth The Diagnosis Of Lower Respiratory Tract Infection
- ClinicalTrials.gov ID
- NCT07183553
- Acronym / sponsor ID
- HITU-SBF-RNY-01
- Conditions
- Lower Respiratory Tract Infection
- Keywords
- Family-centered care, high-flow nasal oxygen therapy, lower respiratory tract infection, respiratory failure, nursing, infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 8 Jul 2025 (actual)
- First posted
- 19 Sep 2025 (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.
This research is an experimental study of randomized control with pre-test - post-test control group.
The aim of this study is to determine the effect of family-centered care approach on physiological parameters and follow-up time in infants with respiratory failure diagnosed with lower respiratory tract infection and receiving high-current oxygen therapy
Detailed description
The population of the study consisted of babies and their mothers who were receiving high-flow nasal oxygen therapy in the baby wards of Ankara Etlik City Hospital between December 2024 and March 2025.After receiving written consents with the volunteer consent form from the mothers who agreed to participate in the study, the volunteers were divided into intervention and control groups using the "computerized randomization method" (www.randomizer.org ). Patients were distributed to two groups according to the randomization list and all groups were informed about how to fill out follow-up forms. In both groups, the data in the section on introductory characteristics of the mother and baby in the first part of the Mother and Baby Introductory Information Form were filled in. A pre-test was administered with the family-centered care scale. The data related to the measurements of life signs (body temperature, pulse, respiration, oxygen saturation and blood pressure) contained in the introductory characteristics section of the baby were obtained from the patient's file and recorded. The intervention group received the "Family-Centered Care Program" and the control group received the standard care program of the clinic.The families in the intervention group were given training and information about family-centered care and were given an educational booklet that had been prepared. Before discharge, a post-test was conducted on both groups using the family-centered care scale.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | – | Other: maintenance trainingAfter completing the data in the first section of the Mother and Baby Introductory Information Form, which includes information about the mother and baby, and the Family-Centered Care Scale, the mothers received one-on-one information, which lasted approximately 30 minutes, based on the content of the prepared education booklet. The education booklet covered topics on family-centered care, clinical equipment, steam application, and postural drainage. The mother was supported by a nurse throughout the care process until discharge. Maternal care practices were implemented under the supervision of the nurse, and questions about care were answered. The Family-Centered Care Scale was administered before discharge. |
| control group | – | –After completing the data in the first section of the Mother and Baby Information Form, which includes information about the mother and baby, and the Family-Centered Care Scale, the mothers were trained by the nurses in accordance with the standard training content of the service. This content included general service rules, general materials used in the service, and a service introduction. Families were also provided with basic information about high nasal flow, including what it means. Care practices were implemented by the nurse until discharge. The Family-Centered Care Scale was administered at discharge. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The study included babies and their mothers who were treated in baby wards and received high-flow nasal oxygen therapy.
Key inclusion criteria (7 listed)
- 18 years of age or older,
- Literate,
- Agreeing to participate in the study,
- Oriented to person, place, and time,
- No visual (except for those with improved vision using visual aids) or auditory communication difficulties (except for those with improved hearing using hearing aids) that would prevent them from understanding and expressing the information provided,
Key exclusion criteria (2 listed)
- Mothers who did not speak or read Turkish,
- who were participating in a different study conducted at the clinic, were not included in the study.
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 |
|---|---|---|
| maintenance traininginformation has been provided in accordance with the content of the training booklet. | Other | intervention group |
Primary outcome
Family Centred Care Scale
Time frame: three days
The Family-Centered Care Scale (FCCS), consists of two sections. Both sections contain the same questions. The scale, divided into two sections for importance and consistency, consists of seven items. Each item is scored from 1 to 5. The lowest possible score is 7, and the highest is 35. As the total score increases, satisfaction with family-centered care increases in direct proportion to the score obtained from the scale. The items consist of questions regarding the evaluation of the nursing care received by parents during their hospital stay. The importance section evaluates the level of care shown by the nurses, and the consistency section evaluates the level of care shown by the nurses in the child's care. In the scale's evaluation, the importance and consistency scores are added together to form a single score.
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 19 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Respiratory Tract Infection, run by Ankara Etlik City Hospital at 1 site 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 7 inclusion and 2 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Family Centred Care Scale (time frame: three days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.