Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers (NCT05302700) | Clinical Trial Compass
CompletedNot Applicable
Effectiveness of Early Parental Sensitivity Intervention for Preterm Infant Mothers
Taiwan68 participantsStarted 2022-11-02
Plain-language summary
In Taiwan, according to the birth notification statistics of the Ministry of Health and Welfare. 164,496 newborns were born in 2020, with preterm births accounting for about 11.58%.Most preterm infants need to be hospitalized for highly specialized care, resulting in the separation of preterm infants from their parents after birth, which may have a negative impact on the healthy attachment development between parents and preterm infants. Moreover, due to the vulnerability of preterm infants, parents often lack the confidence to take care of them.
Who can participate
Age range
20 Years – 55 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Preterm infants:
. Preterm infants less than 37 weeks gestation and hospitalized in the NICU
. The birth weight is classified as VLBW and LBW, and the birth weight is between 1,000-2,499gm
. Preterm infant mothers:
. Children have not been hospitalized in the NICU in the past
. At least 20 years old
. They can speak Chinese, Taiwanese fluently and need to be literate
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maternal Attachment Inventory
Timeframe: On the fifth to seventh day after birth of preterm infant.
2
Maternal Confidence Questionnaire
Timeframe: On the fifth to seventh day after birth of preterm infant.
3
Parental Stressor Scale: Infant Hospitalization
Timeframe: On the fifth to seventh day after birth of preterm infant.