Premature InfantNCT04648787
A Study of Family-integrated Care for Reducing Uncertainty
A study testing family-integrated care and traditional nursing in people with Premature Infant, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. Read more about this study
- Who is it for?
- Ages 1 hour to 2 months
- Conditions the study is for
- Premature Infant
- What is being tested?
- family-integrated care and traditional nursing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2020to 31 Dec 2023
- 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 1 hour to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children:
- 32 weeks < gestational age < 37 weeks
- Birth weight ≤ 2500g
- Apgar score > 7
- Transferred to our hospital within 8 hours after birth
- Parents:
- Have normal communication ability and understanding ability
- Agreed to participate in this study
Who cannot join
- Children:
- -With serious life-threatening diseases, the neonatal critical cases score (discussion draft) was rated as "extremely critical"
- Parents:
- -There are serious diseases or major negative events in the family (such as traffic accidents, natural disasters, etc.)
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants
To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. The study will be described the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.
Read the detailed description
Most of the current management mode of restricting or forbidding visiting in neonatology, parents can not establish the perception of premature infants and lack of communication with medical staff, which will lead to negative emotions represented by uncertainty of disease.The research on uncertainty of disease started late in China, mostly used in tumor, epilepsy and congenital heart disease. The research on parents of NICU children mostly focused on the analysis of influencing factors of uncertainty of disease, lacking intervention research, and the measures were only the information support mode based on health education. We want to explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. Describe the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.
- Conditions
- Premature Infant
- Being tested
- family-integrated care, traditional nursing
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
family-integrated careBehavioural
One week after admission, the parents of premature infants were informed by telephone one day in advance to enter the ward for family participation nursing, and the guidance of daily life nursing for premature infants was given on the same day, including hand hygiene, breast feeding, pacification, changing diapers, bathing and establishment of parent-child relationship. Before discharge, theparents of premature infants should be informed by telephone one day in advance to enter the ward again for family participation nursing, and half a day's guidance was given, including observation and treatment of common symptoms and signs, guidance of home safety prevention and learning to write diary of premature infants.
traditional nursingBehavioural
In hospital education: the health education manual for premature infants will be issued at the time of discharge; the patient's condition will be answered by telephone from 14:00 to 16:00 every day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group: traditional nursing with family-integrated care | Experimental | traditional nursing with family-integrated care Receives: Behavioral: family-integrated care |
| Control group: traditional nursing | Experimental | traditional nursing Receives: Behavioral: traditional nursing |
What is being measured
The primary outcome is the main question the study is designed to answer.
The total Scores of PPUS(Parents' Perception of Uncertainty Scale )
The scale is one of a series of uncertainty scales developed by Mishel in 1998 under the guidance of uncertainty theory of disease, which is one of the series of uncertainty scales for different groups of people. Its content includes 4 dimensions, 31 items, unclear (13 items), complexity (9 items), lack of information (5 items), and unpredictable (4 items). It includes one score from 4 dimensions adding. The score is much higher, the parents maybe feel more uncertainty.According to the response of the responders, from "completely disagree" to "completely agree", the total score is "31-155". The higher the score is, the stronger the uncertainty of the disease is. When the total score is more than 50% of the highest score, the responders are considered to have higher uncertainty of the disease.
Measured: from adminssion to discharge (almostly 14 hospitalization days )
Secondary outcomes (1)
The Scores of Family satisfaction
Likert 5-point method was used to score, that is, 2 = very dissatisfied, 4 = dissatisfied, 6 = average, 8 = satisfied and 10 = very satisfied. The satisfaction level of each question was quantified by scoring.satisfied, satisfied and very satisfied with the score of inpatient satisfaction in the total number of discharged children.
Measured: The 30th day after discharge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start30 Nov 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature InfantStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ping ge qian, bachelor, Study chair, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648787
- Sponsor's protocol ID
- gepingqian
- Status last verified
- Oct 2026
- First submitted
- 24 Nov 2020
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Intervention Study of Family-integrated Care for Reducing Uncertainty About Illness in Parents of Preterm Infants
- ClinicalTrials.gov ID
- NCT04648787
- Acronym / sponsor ID
- gepingqian
- Conditions
- Premature Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Dec 2020 (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.
To explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. The study will be described the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.
Detailed description
Most of the current management mode of restricting or forbidding visiting in neonatology, parents can not establish the perception of premature infants and lack of communication with medical staff, which will lead to negative emotions represented by uncertainty of disease.The research on uncertainty of disease started late in China, mostly used in tumor, epilepsy and congenital heart disease. The research on parents of NICU children mostly focused on the analysis of influencing factors of uncertainty of disease, lacking intervention research, and the measures were only the information support mode based on health education. We want to explore the intervention effect of family participatory nursing on the uncertainty of illness of parents of hospitalized premature infants, and to evaluate the uncertainty level of parents of premature infants in different stages. Describe the feeling of parents of premature infants after family participation nursing through interview. We will provide support for families of premature infants, and then to provide support for growth and development of premature infants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group: traditional nursing with family-integrated care | Experimental | Behavioral: family-integrated caretraditional nursing with family-integrated care |
| Control group: traditional nursing | Experimental | Behavioral: traditional nursingtraditional nursing |
Who may qualify
- Ages
- 1 hour to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 32 weeks < gestational age < 37 weeks
- Birth weight ≤ 2500g
- Apgar score > 7
- Transferred to our hospital within 8 hours after birth
- Have normal communication ability and understanding ability
Key exclusion criteria (4 listed)
- -With serious life-threatening diseases, the neonatal critical cases score (discussion draft) was rated as "extremely critical"
- -There are serious diseases or major negative events in the family (such as traffic accidents, natural disasters, etc.)
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-integrated careOne week after admission, the parents of premature infants were informed by telephone one day in advance to enter the ward for family participation nursing, and the guidance of daily life nursing for premature infants was given on the same day, including hand hygiene, breast feeding, pacification, changing diapers, bathing and establishment of parent-child relationship. Before discharge, theparents of premature infants should be informed by telephone one day in advance to enter the ward again for family participation nursing, and half a day's guidance was given, including observation and treatment of common symptoms and signs, guidance of home safety prevention and learning to write diary of premature infants. | Behavioural | Intervention group: traditional nursing with family-integrated care |
| traditional nursingIn hospital education: the health education manual for premature infants will be issued at the time of discharge; the patient's condition will be answered by telephone from 14:00 to 16:00 every day. | Behavioural | Control group: traditional nursing |
Primary outcome
The total Scores of PPUS(Parents' Perception of Uncertainty Scale )
Time frame: from adminssion to discharge (almostly 14 hospitalization days )
The scale is one of a series of uncertainty scales developed by Mishel in 1998 under the guidance of uncertainty theory of disease, which is one of the series of uncertainty scales for different groups of people. Its content includes 4 dimensions, 31 items, unclear (13 items), complexity (9 items), lack of information (5 items), and unpredictable (4 items). It includes one score from 4 dimensions adding. The score is much higher, the parents maybe feel more uncertainty.According to the response of the responders, from "completely disagree" to "completely agree", the total score is "31-155". The higher the score is, the stronger the uncertainty of the disease is. When the total score is more than 50% of the highest score, the responders are considered to have higher uncertainty of the disease.
1 secondary outcome
The Scores of Family satisfaction
Time frame: The 30th day after discharge.
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 26 Oct 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.
ping ge qian, bachelor study chair
Children's Hospital of Fudan University
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-integrated care and traditional nursing in people with Premature Infant, run by Children's Hospital of Fudan University at 1 site in China.
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 8 inclusion and 4 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 26 Oct 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 China. 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?
The total Scores of PPUS(Parents' Perception of Uncertainty Scale ) (time frame: from adminssion to discharge (almostly 14 hospitalization 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 26 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.