PrematurityNCT07834008
Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns
A study testing step-by-step parent education and active father participation in breastfeeding support in people with Prematurity and Low Birth Weight, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
Trial summary
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care. Parents of high-risk newborns admitted to a neonatal intermediate care unit will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn
- What is being tested?
- step-by-step parent education and active father participation in breastfeeding support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 1 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Both parents must be 18 years of age or older.
- Both parents must live in the same residence.
- Both parents must be able to communicate in Mandarin Chinese or Taiwanese.
- Their child must be a high-risk newborn admitted to the neonatal intermediate care ward for at least three days.
- Their child must not have returned home after admission to the neonatal intermediate care ward.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare
New Taipei City, 235
About this study
Official title: The Effectiveness of Paternal Involvement in Nursing Guidance on Spousal Support and Breastfeeding Self-efficacy for Mothers of High-risk Newborns
This study aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
Parents of high-risk newborns admitted to a neonatal intermediate care unit will be enrolled. Families in the control group will receive routine nursing education provided during hospitalization. Families in the intervention group will receive a structured nursing guidance program that includes step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care.
The study will compare the two groups on maternal breastfeeding self-efficacy, perceived spousal support, perceived nursing support, parental stress, breastfeeding-related anxiety, and breastfeeding practices at hospital discharge and one month after discharge. The findings may help develop family-centered nursing interventions that enhance paternal involvement and improve breastfeeding outcomes for families with high-risk newborns.
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia, Diarrhea
- Being tested
- step-by-step parent education, active father participation in breastfeeding support
- Keywords
- High-risk newborns, Fathers, Father involvement, nursing education provided, breastfeeding, Parental participation
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome, Newborn, Hyperbilirubinemia, Neonatal, Diarrhea, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
step-by-step parent educationBehavioural
Parents will receive structured, step-by-step education on breastfeeding and infant care. The education will be provided through nursing guidance, written educational materials, and instructional videos to facilitate parents' understanding and application of recommended breastfeeding and infant-care practices.
active father participation in breastfeeding supportBehavioural
Fathers will be actively involved in the breastfeeding process and infant care. They will be encouraged to provide practical, emotional, and informational support to mothers, thereby helping mothers establish and maintain breastfeeding and share responsibilities for infant care.
| Study group | Role | What they receive |
|---|---|---|
| Step-by-step Parent Education and Active Father Participation | Experimental | Families assigned to the intervention group will receive a structured nursing guidance program designed to improve parents' knowledge, skills, and confidence in breastfeeding and infant care. The program will include step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care. Fathers will be encouraged to provide practical, emotional, and informational support to mothers throughout the breastfeeding process. Receives: Behavioral: step-by-step parent education; Behavioral: active father participation in breastfeeding support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Breastfeeding Self-Efficacy Score measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Maternal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a 14-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 1 (not at all confident) to 5 (always confident). Total scores range from 14 to 70, with higher scores indicating greater maternal breastfeeding self-efficacy.
Measured: At the baseline, pre-intervention, and 1 month after hospital discharge.
Secondary outcomes (1)
Maternal Perceived Spousal Support Score measured by the Spousal Parenting Support Scale
Maternal perceived spousal support will be assessed using the Spousal Parenting Support Scale (maternal version), a 22-item questionnaire assessing the mother's perception of her spouse's support in parenting and caregiving. Each item is rated on a 5-point Likert scale from 1 (never) to 5 (always). Total scores range from 22 to 110, with higher scores indicating greater perceived spousal support.
Measured: At the baseline, pre-intervention, and 1 month after hospital discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematurityStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Shuang Ho Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07834008
- Sponsor's protocol ID
- N202606058
- Status last verified
- Aug 2026
- First submitted
- 7 Aug 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Paternal Involvement in Nursing Guidance on Spousal Support and Breastfeeding Self-efficacy for Mothers of High-risk Newborns
- ClinicalTrials.gov ID
- NCT07834008
- Acronym / sponsor ID
- N202606058
- Conditions
- Prematurity, Low Birth Weight, Respiratory Distress Syndrome, Newborn, Neonatal Hyperbilirubinemia, Diarrhea
- Keywords
- High-risk newborns, Fathers, Father involvement, nursing education provided, breastfeeding, Parental participation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 22 Sep 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 aims to evaluate whether a structured nursing guidance program that increases fathers' participation in the care of hospitalized high-risk newborns improves maternal outcomes compared with routine nursing care.
Parents of high-risk newborns admitted to a neonatal intermediate care unit will be enrolled. Families in the control group will receive routine nursing education provided during hospitalization. Families in the intervention group will receive a structured nursing guidance program that includes step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care.
The study will compare the two groups on maternal breastfeeding self-efficacy, perceived spousal support, perceived nursing support, parental stress, breastfeeding-related anxiety, and breastfeeding practices at hospital discharge and one month after discharge. The findings may help develop family-centered nursing interventions that enhance paternal involvement and improve breastfeeding outcomes for families with high-risk newborns.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Step-by-step Parent Education and Active Father Participation | Experimental | Behavioral: step-by-step parent education, Behavioral: active father participation in breastfeeding supportFamilies assigned to the intervention group will receive a structured nursing guidance program designed to improve parents' knowledge, skills, and confidence in breastfeeding and infant care. The program will include step-by-step parent education, written educational materials, instructional videos, and active father participation in breastfeeding support and infant care. Fathers will be encouraged to provide practical, emotional, and informational support to mothers throughout the breastfeeding process. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Both parents must be 18 years of age or older.
- Both parents must live in the same residence.
- Both parents must be able to communicate in Mandarin Chinese or Taiwanese.
- Their child must be a high-risk newborn admitted to the neonatal intermediate care ward for at least three days.
- Their child must not have returned home after admission to the neonatal intermediate care ward.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| step-by-step parent educationParents will receive structured, step-by-step education on breastfeeding and infant care. The education will be provided through nursing guidance, written educational materials, and instructional videos to facilitate parents' understanding and application of recommended breastfeeding and infant-care practices. | Behavioural | Step-by-step Parent Education and Active Father Participation |
| active father participation in breastfeeding supportFathers will be actively involved in the breastfeeding process and infant care. They will be encouraged to provide practical, emotional, and informational support to mothers, thereby helping mothers establish and maintain breastfeeding and share responsibilities for infant care. | Behavioural | Step-by-step Parent Education and Active Father Participation |
Primary outcome
Maternal Breastfeeding Self-Efficacy Score measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF)
Time frame: At the baseline, pre-intervention, and 1 month after hospital discharge.
Maternal breastfeeding self-efficacy will be assessed using the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF), a 14-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 1 (not at all confident) to 5 (always confident). Total scores range from 14 to 70, with higher scores indicating greater maternal breastfeeding self-efficacy.
1 secondary outcome
Maternal Perceived Spousal Support Score measured by the Spousal Parenting Support Scale
Time frame: At the baseline, pre-intervention, and 1 month after hospital discharge.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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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 step-by-step parent education and active father participation in breastfeeding support in people with Prematurity and Low Birth Weight, run by Taipei Medical University Shuang Ho Hospital at 1 site in Taiwan.
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 5 inclusion and 0 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: under way, not looking for participants, as of the sponsor's last update on 22 Sep 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 Taiwan. 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?
This study is still under way. Results are not available in the source record yet.
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?
Maternal Breastfeeding Self-Efficacy Score measured by the Breastfeeding Self-Efficacy Scale-Short Form (BSES-SF) (time frame: At the baseline, pre-intervention, and 1 month after hospital discharge.). 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 22 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.