Risky BabyNCT07534748
Short-term Neonatal and Parental Outcomes in Low- and High-Risk Infants
A study testing Family Care Intervention in people with Risky Baby, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included. All parents received a structured, family care education during hospitalization. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Risky Baby
- What is being tested?
- Family Care Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 1 Jan 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Infants whose families declined participation in the study.
- Infants with congenital anomalies.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Afyonkarahisar Health Sciences University Hospital
Afyonkarahisar
About this study
Official title: Short Term Neonatal and Parents Outcomes in Low and High Risk Infants Undergoing Family Care Intervention
This study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.
All parents received a structured, family care education during hospitalization. Parental depression, anxiety, care participation, and neonatal pain were assessed on the 10th day of hospitalization and at discharge.
- Conditions
- Risky Baby
- Being tested
- Family Care Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family Care InterventionOther
A structured, family care education was provided to parents of hospitalized neonates. The session focused on promoting parental involvement in infant care, reducing parental anxiety and depression, and minimizing neonatal pain. The intervention was delivered individually to each parent-infant dyad during hospitalization and included guidance on routine neonatal care, recognizing and responding to infant cues, and supportive strategies for high-risk infants.
| Study group | Role | What they receive |
|---|---|---|
| Family Care Intervention | Other | Not described Receives: Other: Family Care Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Care Participation
In this study, the "Care Participation Assessment Scale for Mothers with Infants Hospitalized in the Neonatal Intensive Care Unit" was used to evaluate the level of maternal participation in the care of their infants. The scale consists of 19 items assessing caregiving practices performed by mothers. Each item is scored dichotomously (Yes/No), with "Yes" scored as 1 and "No" as 0. The total score ranges from 0 to 19, with higher scores indicating greater participation in infant care.
Measured: 1 year
Edinburgh Postnatal Depression Scale
In this study, the Edinburgh Postnatal Depression Scale was used to assess postpartum depressive symptoms. The scale consists of 10 items, each scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms.
Measured: 1 year
State-Trait Anxiety
In this study, the State-Trait Anxiety Inventory was used to assess anxiety levels. The scale consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T), each comprising 20 items. Items are rated on a 4-point Likert scale, and total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety.
Measured: 1 year
Neonatal Pain
In this study, the Neonatal Infant Pain Scale was used to assess pain in neonates. The scale consists of 6 items evaluating facial expression, cry, breathing patterns, arm and leg movements, and state of arousal. Each item is scored between 0 and 1, except for crying, which is scored between 0 and 2. The total score ranges from 0 to 7, with higher scores indicating greater pain intensity.
Measured: 1 year
Secondary outcomes (1)
Neurological Risk Level
In this study, neurological risk level was assessed using the Dubowitz Neurological Examination. This standardized assessment evaluates neonatal neurological function, including tone, reflexes, movements, and behavioral responses. The total score ranges from 0 to 34, with higher scores indicating better neurological status and lower neurological risk.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start1 Jan 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risky BabyStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Müşerref Ebru YALÇIN, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534748
- Sponsor's protocol ID
- E-69996495-100-34196
- Status last verified
- Aug 2021
- First submitted
- 4 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Term Neonatal and Parents Outcomes in Low and High Risk Infants Undergoing Family Care Intervention
- ClinicalTrials.gov ID
- NCT07534748
- Acronym / sponsor ID
- E-69996495-100-34196
- Conditions
- Risky Baby
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 16 Apr 2026 (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 study aimed to evaluate the short-term neonatal and parental outcomes in low- and high-risk infants following a single-session family care education intervention. A total of 34 parent-infant dyads were included.
All parents received a structured, family care education during hospitalization. Parental depression, anxiety, care participation, and neonatal pain were assessed on the 10th day of hospitalization and at discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Family Care Intervention | Other | Other: Family Care Intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- Infants whose families declined participation in the study.
- Infants with congenital anomalies.
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 |
|---|---|---|
| Family Care InterventionA structured, family care education was provided to parents of hospitalized neonates. The session focused on promoting parental involvement in infant care, reducing parental anxiety and depression, and minimizing neonatal pain. The intervention was delivered individually to each parent-infant dyad during hospitalization and included guidance on routine neonatal care, recognizing and responding to infant cues, and supportive strategies for high-risk infants. | Other | Family Care Intervention |
Primary outcome
Parental Care Participation
Time frame: 1 year
In this study, the "Care Participation Assessment Scale for Mothers with Infants Hospitalized in the Neonatal Intensive Care Unit" was used to evaluate the level of maternal participation in the care of their infants. The scale consists of 19 items assessing caregiving practices performed by mothers. Each item is scored dichotomously (Yes/No), with "Yes" scored as 1 and "No" as 0. The total score ranges from 0 to 19, with higher scores indicating greater participation in infant care.
Edinburgh Postnatal Depression Scale
Time frame: 1 year
In this study, the Edinburgh Postnatal Depression Scale was used to assess postpartum depressive symptoms. The scale consists of 10 items, each scored on a 4-point Likert scale (0-3). The total score ranges from 0 to 30, with higher scores indicating greater severity of depressive symptoms.
State-Trait Anxiety
Time frame: 1 year
In this study, the State-Trait Anxiety Inventory was used to assess anxiety levels. The scale consists of two subscales: state anxiety (STAI-S) and trait anxiety (STAI-T), each comprising 20 items. Items are rated on a 4-point Likert scale, and total scores for each subscale range from 20 to 80, with higher scores indicating greater levels of anxiety.
Neonatal Pain
Time frame: 1 year
In this study, the Neonatal Infant Pain Scale was used to assess pain in neonates. The scale consists of 6 items evaluating facial expression, cry, breathing patterns, arm and leg movements, and state of arousal. Each item is scored between 0 and 1, except for crying, which is scored between 0 and 2. The total score ranges from 0 to 7, with higher scores indicating greater pain intensity.
1 secondary outcome
Neurological Risk Level
Time frame: 1 year
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 16 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Risky Baby
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Are Developmentally At Risky Babies Environmentally Disadvantaged?
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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?
A study testing Family Care Intervention in people with Risky Baby, run by Inonu University 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 0 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 16 Apr 2026. 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?
Parental Care Participation (time frame: 1 year). The study lists 4 primary outcomes in all. 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 16 Apr 2026.