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Active, not recruitingNCT07834008Updated Sep 22, 2026

Paternal Involvement in Nursing Guidance and Breastfeeding Self-Efficacy in Mothers of High-Risk Newborns

An interventional study of step-by-step parent education and active father participation in breastfeeding support in Prematurity, Low Birth Weight and Respiratory Distress Syndrome, Newborn, sponsored by Taipei Medical University Shuang Ho Hospital. Active, not recruiting at 1 site in Taiwan. Open to participants aged 18 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by Taipei Medical University Shuang Ho Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 26 studies in Premature Birth with a site in Taiwan — 3 open to participants now, 6 under way, none of them phase 3. Premature Birth · Taiwan.

Enrollment
11th of 14
80 · median 110
Started
2026
the only one that year
No phase
12 of 26
2 open now
Registered
26th of 26
by date
Lead sponsor
1 of 26
Taipei Medical University Shuang Ho Hospital

Among the 26 studies in Premature Birth with a site in Taiwan, this one is the 11th largest by enrollment of the 14 interventional ones that give a count, is the only one that started in 2026, is one of 12 with no phase, and was the 26th registered.

Premature Birth

2,553 studies on the registry are indexed under Premature Birth; 502 are open to participants now.

Browse Premature Birth studies →

Open to participants now

3 of the 26 studies in Premature Birth with a site in Taiwan are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Taiwan have not opened yet or have stopped. Only those recruiting at a site in Taiwan →

Who these studies take

Of the 315 Premature Birth studies recruiting now, 88 (28%) set no upper age limit and 223 (71%) stop at 75 or younger; 241 take children under 18; 105 take healthy volunteers.

This study: 18 Years to 100 Years · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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. 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.

03

Conditions studied

  • Prematurity
  • Low Birth Weight
  • Respiratory Distress Syndrome, Newborn
  • Neonatal Hyperbilirubinemia
  • Diarrhea

Keywords

  • High-risk newborns
  • Fathers
  • Father involvement
  • nursing education provided
  • breastfeeding
  • Parental participation
04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Step-by-step Parent Education and Active Father Participation

    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.

    Behavioral: step-by-step parent education · Behavioral: active father participation in breastfeeding support

Interventions

  • Behavioralstep-by-step parent education

    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.

  • Behavioralactive father participation in breastfeeding support

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: At the baseline, pre-intervention, and 1 month after hospital discharge.

Other outcomes

  1. Maternal Perceived Nursing Staff Support Score measured by the Nursing Staff Support Scale

    Maternal perceived nursing staff support will be assessed using the Nursing Staff Support Scale, a 21-item questionnaire assessing the support provided by nursing staff during the infant's hospitalization. Each item is rated on a 5-point Likert scale from 1 (never) to 5 (always). Total scores range from 21 to 105, with higher scores indicating greater perceived nursing staff support.

    Time frame: At thebaseline, pre-intervention.

  2. Maternal Perceived Stress Score measured by the Perceived Stress Scale

    Maternal perceived stress will be assessed using the Perceived Stress Scale (PSS), a 10-item self-report questionnaire. Each item is rated on a 5-point scale from 0 (never) to 4 (very often). Total scores range from 0 to 40, with higher scores indicating greater perceived stress.

    Time frame: At thebaseline, pre-intervention, and 1 month after hospital discharge.

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 12 months after the start.

Of 744 non-industry interventional studies with no phase under Premature Birth, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 47. This study's planned 12 months is below that.

Counting every sponsor, half of 762 studies reached it within 24 months; a quarter within 12 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 7, 2026
First posted
Sep 22, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Aug 1, 2027
CompletionEst.
Aug 1, 2027
Last update
Sep 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07834008
Responsible party
Sponsor
First posted
Sep 22, 2026
Start date
Aug 1, 2026
Primary completion
Aug 1, 2027 (estimated)
Completion
Aug 1, 2027 (estimated)
Last update
Sep 22, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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