Patient DischargeNCT06613386
Effects of an Information-Based Discharge Service on Preterm Infants, Parents, and Hospitals
A study testing The information-based discharge preparation service (IBDPS) in people with Patient Discharge and Infant, Premature, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied. Read more about this study
- Who is it for?
- Ages Up to 37 weeks
- Conditions the study is for
- Patient Discharge, Infant, Premature
- What is being tested?
- The information-based discharge preparation service (IBDPS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Oct 2024to Mar 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 Up to 37 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants with a gestational age of less than 37 weeks at birth.
- Written informed consent obtained from legal guardians.
- Neonates delivered at the study hospital or transferred within the first 24 hours of life.
- Parents of infants born at less than 37 weeks of gestational age.
- Written informed consent provided by the parents.
- Ability to dedicate at least 4 hours per day to infant care.
- Adequate reading comprehension and proficiency in using electronic devices.
- If multiple caregivers are involved, the primary caregiver with the most hours of caregiving will be selected.
Who cannot join
- Presence of major life-threatening congenital anomalies.
- Critical illness or conditions requiring immediate intensive intervention.
- Significant developmental abnormalities, including but not limited to severe congenital malformations, metabolic disorders, or central nervous system anomalies.
- Removal Criteria for Infants:
- Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.
- Health, familial, social, or language barriers that impair effective integration into the healthcare team.
Show all 9Show fewer
- Removal Criteria for Parents:
- Voluntary withdrawal from the study.
- Non-compliance with study protocols.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant, Parent, and Hospital: a Randomized Controlled Trial
Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied.
Objective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs.
Read more
Design: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China.
Participants: Preterm infants and their parents.
Methods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.
Read the detailed description
Participants are randomly allocated to the intervention and control groups. The intervention group receives the IBDPS in addition to the usual care, while the control group receives only the usual discharge education. The IBDPS, grounded in the theories of empowerment and "Timing It Right (TIR)," leverages an information-based platform to provide continuous, multidimensional, and customized support to parents from their infants' admission to one month post-discharge, ensuring seamless integration of discharge preparation both online and offline, and within and outside the hospital. Baseline data are collected at allocation (T1). Parental outcomes, including readiness for hospital discharge and stress, are assessed at T1, upon NICU entry (T2), and prior to discharge (T3), while caregiving skills are measured at T1, T2, T3, and one month post-discharge (T4). Parental satisfaction is measured at T3. Infant outcomes, such as weight, length, head circumference, breastfeeding rate, and feeding intolerance rate, are recorded at T1, T2, T3, and T4, with Neonatal Behavior Neurologic Assessment (NBNA) scores evaluated at T4. Hospital outcomes include length of stay and hospitalization costs, assessed at T3, and unplanned readmissions, recorded at T4.
- Conditions
- Patient Discharge, Infant, Premature
- Being tested
- The information-based discharge preparation service (IBDPS)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The information-based discharge preparation service (IBDPS)Other
The main modules of the IBDPS platform include:
- Establishing information records for infants and parents.
- Collaboratively identifying existing or potential caregiving challenges.
- Assessing parents' emotional and psychological states, providing support and intervention.
- Collaboratively establishing caregiving objectives with parents.
- Collaboratively formulating and executing caregiving plans.
- Assessing parental support resources, offering analysis, assistance, and necessary referrals.
- Conducting outcome assessments.
| Study group | Role | What they receive |
|---|---|---|
| IBDPS intervention | Experimental | Caregivers receive the IBDPS alongside usual care.
* Grounded in the theories of empowerment and "Timing It Right" (TIR), the IBDPS delivers continuous, individualized support through an information-based platform from admission to one month postdischarge, facilitating seamless integration of discharge preparation across both online and offline environments.
* Upon admission, caregivers register via WeChat, receiving tailored, stage-specific guidance on key topics such as "Growth," "Feeding," and "Sleep," aligned with the evolving needs of preterm infants. They can submit nursing concerns and assess their emotional state, with healthcare providers offering ongoing guidance. When the infant's condition stabilizes, caregivers can schedule NICU visits and engage in supervised bedside care training. Prior to discharge, hands-on training is provided. Postdischarge, caregivers upload growth data for continuous monitoring, with the option of home nurse visits. Receives: Other: The information-based discharge preparation service (IBDPS) |
| Usual care | No intervention | Receive the usual care. * Routine admission education includes inpatient guidelines, breast milk storage, and receiving processes. * During hospitalization, healthcare providers are responsible for all infant care. Caregivers can visit three times a week at scheduled times, with visiting days arranged by the odd or even numbers of the inpatient ID. Visits are conducted via live video, allowing caregivers to consult with doctors about the infant's condition. * Upon discharge, healthcare providers educate caregivers on discharge precautions and preterm infant care methods. * Follow-up is conducted through phone calls and outpatient visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readiness for Hospital Discharge Scale
The Readiness for Hospital Discharge Scale (RHDS) - Parent Form was originally developed by Weiss et al. for assessing the readiness of parents for the discharge of their hospitalized children (0 to 18 years old). The Chinese version of the Readiness for Hospital Discharge Scale (C-RHDS) - Parent Form, adapted by Chen et al. with authorization from the original authors, is utilized to evaluate the readiness of parents for the discharge of preterm infants. This 22-item scale includes four dimensions: Knowledge (9 items), Physical-emotional Status (7 items), Pain Status (2 items), and Expected Support (4 items). Each item is scored on a scale from 0 to 10 (0 = worst; 10 = best), with total scores ranging from 0 to 220. Higher scores reflect better readiness for discharge. The overall Cronbach α coefficient for this scale is 0.91.
Measured: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.
Secondary outcomes (1)
Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants
The Chinese version of the Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants, developed by Meng et al., is used to evaluate the caregiving ability of parents with preterm infants. This questionnaire consists of 18 items rated on a Likert scale from 1 to 5 (1 = not at all familiar; 5 = very familiar). It is divided into three dimensions: Knowledge of Preterm Infant Care (7 items), Caregiving Skills (7 items), and Caregiving Ability (4 items). The total score ranges from 18 to 90, with higher scores indicating better caregiving ability. The Cronbach α coefficient for the overall scale is 0.956.
Measured: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Patient DischargeStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study employs a prospective, double-arm, randomized controlled trial (RCT) design, conducted in the Neonatal Intensive Care Units (NICU) of a tertiary first-class hospital in Jiangsu Province, China.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese Medical Association
- Responsible party
- Sponsor
- Investigators
- Caoyuan Wang, Master, Study director, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06613386
- Sponsor's protocol ID
- JSPH-NC-2022-18
- Status last verified
- Sep 2024
- First submitted
- 27 Aug 2024
- Last updated
- 26 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang J, Cao M, Yue S, Yan J, Shang Y. Exploring Effect of Postdischarge Developmental Support Program on Preterm Infant Neurodevelopment and BDNF Gene DNA Methylation. Adv Neonatal Care. 2023 Apr 1;23(2):E50-E58. doi: 10.1097/ANC.0000000000001046. Epub 2022 Nov 21.
PubMed 36409665Cao G, Liu J, Liu M. Global, Regional, and National Incidence and Mortality of Neonatal Preterm Birth, 1990-2019. JAMA Pediatr. 2022 Aug 1;176(8):787-796. doi: 10.1001/jamapediatrics.2022.1622.
PubMed 35639401Smith VC, Mao W, McCormick MC. Changes in Assessment of and Satisfaction With Discharge Preparation From the Neonatal Intensive Care Unit. Adv Neonatal Care. 2021 Oct 1;21(5):E144-E151. doi: 10.1097/ANC.0000000000000862.
PubMed 33852448O'Connor M, Moriarty H, Schneider A, Dowdell EB, Bowles KH. Patients' and caregivers' perspectives in determining discharge readiness from home health. Geriatr Nurs. 2021 Jan-Feb;42(1):151-158. doi: 10.1016/j.gerinurse.2020.12.012. Epub 2021 Jan 11.
PubMed 33444923Hua W, Wang L, Li C, Simoni JM, Yuwen W, Jiang L. Understanding preparation for preterm infant discharge from parents' and healthcare providers' perspectives: Challenges and opportunities. J Adv Nurs. 2021 Mar;77(3):1379-1390. doi: 10.1111/jan.14676. Epub 2020 Nov 29.
PubMed 33249653Azzuqa A, Chuo J, Zenge J. Tele-medicine: Innovative tools for a safe transition to home in neonatal care. Semin Perinatol. 2021 Aug;45(5):151427. doi: 10.1016/j.semperi.2021.151427. Epub 2021 Apr 6. No abstract available.
PubMed 34006383Banerjee J, Aloysius A, Mitchell K, Silva I, Rallis D, Godambe SV, Deierl A. Improving infant outcomes through implementation of a family integrated care bundle including a parent supporting mobile application. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):172-177. doi: 10.1136/archdischild-2018-316435. Epub 2019 Jun 21.
PubMed 31227521Richardson B, Dol J, Rutledge K, Monaghan J, Orovec A, Howie K, Boates T, Smit M, Campbell-Yeo M. Evaluation of Mobile Apps Targeted to Parents of Infants in the Neonatal Intensive Care Unit: Systematic App Review. JMIR Mhealth Uhealth. 2019 Apr 15;7(4):e11620. doi: 10.2196/11620.
PubMed 30985282Zhang R, Huang RW, Gao XR, Peng XM, Zhu LH, Rangasamy R, Latour JM. Involvement of Parents in the Care of Preterm Infants: A Pilot Study Evaluating a Family-Centered Care Intervention in a Chinese Neonatal ICU. Pediatr Crit Care Med. 2018 Aug;19(8):741-747. doi: 10.1097/PCC.0000000000001586.
PubMed 29781955Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.
PubMed 27990350
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of an Information-Based Discharge Preparation Service on the Outcomes of Preterm Infant, Parent, and Hospital: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06613386
- Acronym / sponsor ID
- JSPH-NC-2022-18
- Conditions
- Patient Discharge, Infant, Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Chinese Medical Association
- Study start
- Oct 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 26 Sep 2024 (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.
Background:The Information-Based Discharge Preparation Service (IBDPS) supports parents of preterm infants during the transition from hospital to home, but its effectiveness has not been widely studied.
Objective:To evaluate the impact of IBDPS on parental readiness, caregiving skills, stress, satisfaction, infant development, readmission rates, length of stay, and hospital costs.
Design: A randomized controlled trial (RCT) in a NICU in Jiangsu Province, China.
Participants: Preterm infants and their parents.
Methods:Participants are randomly assigned to receive either IBDPS plus usual care (intervention group) or usual care alone (control group). Data on parental and infant outcomes are collected at various stages from admission to one month post-discharge, along with hospital metrics like length of stay and readmission rates.
Detailed description
Participants are randomly allocated to the intervention and control groups. The intervention group receives the IBDPS in addition to the usual care, while the control group receives only the usual discharge education. The IBDPS, grounded in the theories of empowerment and "Timing It Right (TIR)," leverages an information-based platform to provide continuous, multidimensional, and customized support to parents from their infants' admission to one month post-discharge, ensuring seamless integration of discharge preparation both online and offline, and within and outside the hospital. Baseline data are collected at allocation (T1). Parental outcomes, including readiness for hospital discharge and stress, are assessed at T1, upon NICU entry (T2), and prior to discharge (T3), while caregiving skills are measured at T1, T2, T3, and one month post-discharge (T4). Parental satisfaction is measured at T3. Infant outcomes, such as weight, length, head circumference, breastfeeding rate, and feeding intolerance rate, are recorded at T1, T2, T3, and T4, with Neonatal Behavior Neurologic Assessment (NBNA) scores evaluated at T4. Hospital outcomes include length of stay and hospitalization costs, assessed at T3, and unplanned readmissions, recorded at T4.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study employs a prospective, double-arm, randomized controlled trial (RCT) design, conducted in the Neonatal Intensive Care Units (NICU) of a tertiary first-class hospital in Jiangsu Province, China.
| Arm | Type | Receives |
|---|---|---|
| IBDPS intervention | Experimental | Other: The information-based discharge preparation service (IBDPS)Caregivers receive the IBDPS alongside usual care. * Grounded in the theories of empowerment and "Timing It Right" (TIR), the IBDPS delivers continuous, individualized support through an information-based platform from admission to one month postdischarge, facilitating seamless integration of discharge preparation across both online and offline environments. * Upon admission, caregivers register via WeChat, receiving tailored, stage-specific guidance on key topics such as "Growth," "Feeding," and "Sleep," aligned with the evolving needs of preterm infants. They can submit nursing concerns and assess their emotional state, with healthcare providers offering ongoing guidance. When the infant's condition stabilizes, caregivers can schedule NICU visits and engage in supervised bedside care training. Prior to discharge, hands-on training is provided. Postdischarge, caregivers upload growth data for continuous monitoring, with the option of home nurse visits. |
| Usual care | No intervention | –Receive the usual care. * Routine admission education includes inpatient guidelines, breast milk storage, and receiving processes. * During hospitalization, healthcare providers are responsible for all infant care. Caregivers can visit three times a week at scheduled times, with visiting days arranged by the odd or even numbers of the inpatient ID. Visits are conducted via live video, allowing caregivers to consult with doctors about the infant's condition. * Upon discharge, healthcare providers educate caregivers on discharge precautions and preterm infant care methods. * Follow-up is conducted through phone calls and outpatient visits. |
Who may qualify
- Ages
- Up to 37 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infants with a gestational age of less than 37 weeks at birth.
- Written informed consent obtained from legal guardians.
- Neonates delivered at the study hospital or transferred within the first 24 hours of life.
- Parents of infants born at less than 37 weeks of gestational age.
- Written informed consent provided by the parents.
Key exclusion criteria (9 listed)
- Presence of major life-threatening congenital anomalies.
- Critical illness or conditions requiring immediate intensive intervention.
- Significant developmental abnormalities, including but not limited to severe congenital malformations, metabolic disorders, or central nervous system anomalies.
- Infants who experience abnormal discharge due to treatment abandonment, death, or transfer to another facility.
- Health, familial, social, or language barriers that impair effective integration into the healthcare team.
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 |
|---|---|---|
| The information-based discharge preparation service (IBDPS)The main modules of the IBDPS platform include: * Establishing information records for infants and parents. * Collaboratively identifying existing or potential caregiving challenges. * Assessing parents' emotional and psychological states, providing support and intervention. * Collaboratively establishing caregiving objectives with parents. * Collaboratively formulating and executing caregiving plans. * Assessing parental support resources, offering analysis, assistance, and necessary referrals. * Conducting outcome assessments. | Other | IBDPS intervention |
Primary outcome
Readiness for Hospital Discharge Scale
Time frame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.
The Readiness for Hospital Discharge Scale (RHDS) - Parent Form was originally developed by Weiss et al. for assessing the readiness of parents for the discharge of their hospitalized children (0 to 18 years old). The Chinese version of the Readiness for Hospital Discharge Scale (C-RHDS) - Parent Form, adapted by Chen et al. with authorization from the original authors, is utilized to evaluate the readiness of parents for the discharge of preterm infants. This 22-item scale includes four dimensions: Knowledge (9 items), Physical-emotional Status (7 items), Pain Status (2 items), and Expected Support (4 items). Each item is scored on a scale from 0 to 10 (0 = worst; 10 = best), with total scores ranging from 0 to 220. Higher scores reflect better readiness for discharge. The overall Cronbach α coefficient for this scale is 0.91.
1 secondary outcome
Self-Assessment Questionnaire for Caregiving Ability of Parents of Preterm Infants
Time frame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, discharge,and one month after discharge,assessed up to 120 days.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2024.
- Background: PubMed 36409665Zhang J, Cao M, Yue S, Yan J, Shang Y. Exploring Effect of Postdischarge Developmental Support Program on Preterm Infant Neurodevelopment and BDNF Gene DNA Methylation. Adv Neonatal Care. 2023 Apr 1;23(2):E50-E58. doi: 10.1097/ANC.0000000000001046. Epub 2022 Nov 21.
- Background: PubMed 35639401Cao G, Liu J, Liu M. Global, Regional, and National Incidence and Mortality of Neonatal Preterm Birth, 1990-2019. JAMA Pediatr. 2022 Aug 1;176(8):787-796. doi: 10.1001/jamapediatrics.2022.1622.
- Background: PubMed 33852448Smith VC, Mao W, McCormick MC. Changes in Assessment of and Satisfaction With Discharge Preparation From the Neonatal Intensive Care Unit. Adv Neonatal Care. 2021 Oct 1;21(5):E144-E151. doi: 10.1097/ANC.0000000000000862.
- Background: PubMed 33444923O'Connor M, Moriarty H, Schneider A, Dowdell EB, Bowles KH. Patients' and caregivers' perspectives in determining discharge readiness from home health. Geriatr Nurs. 2021 Jan-Feb;42(1):151-158. doi: 10.1016/j.gerinurse.2020.12.012. Epub 2021 Jan 11.
- Background: PubMed 33249653Hua W, Wang L, Li C, Simoni JM, Yuwen W, Jiang L. Understanding preparation for preterm infant discharge from parents' and healthcare providers' perspectives: Challenges and opportunities. J Adv Nurs. 2021 Mar;77(3):1379-1390. doi: 10.1111/jan.14676. Epub 2020 Nov 29.
- Background: PubMed 34006383Azzuqa A, Chuo J, Zenge J. Tele-medicine: Innovative tools for a safe transition to home in neonatal care. Semin Perinatol. 2021 Aug;45(5):151427. doi: 10.1016/j.semperi.2021.151427. Epub 2021 Apr 6. No abstract available.
- Background: PubMed 31227521Banerjee J, Aloysius A, Mitchell K, Silva I, Rallis D, Godambe SV, Deierl A. Improving infant outcomes through implementation of a family integrated care bundle including a parent supporting mobile application. Arch Dis Child Fetal Neonatal Ed. 2020 Mar;105(2):172-177. doi: 10.1136/archdischild-2018-316435. Epub 2019 Jun 21.
- Background: PubMed 30985282Richardson B, Dol J, Rutledge K, Monaghan J, Orovec A, Howie K, Boates T, Smit M, Campbell-Yeo M. Evaluation of Mobile Apps Targeted to Parents of Infants in the Neonatal Intensive Care Unit: Systematic App Review. JMIR Mhealth Uhealth. 2019 Apr 15;7(4):e11620. doi: 10.2196/11620.
- Background: PubMed 29781955Zhang R, Huang RW, Gao XR, Peng XM, Zhu LH, Rangasamy R, Latour JM. Involvement of Parents in the Care of Preterm Infants: A Pilot Study Evaluating a Family-Centered Care Intervention in a Chinese Neonatal ICU. Pediatr Crit Care Med. 2018 Aug;19(8):741-747. doi: 10.1097/PCC.0000000000001586.
- Background: PubMed 27990350Garfield CF, Lee YS, Kim HN, Rutsohn J, Kahn JY, Mustanski B, Mohr DC. Supporting Parents of Premature Infants Transitioning from the NICU to Home: A Pilot Randomized Control Trial of a Smartphone Application. Internet Interv. 2016 May;4(Pt 2):131-137. doi: 10.1016/j.invent.2016.05.004. Epub 2016 Jun 4.
- Individual participant dataSharing planned: No
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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.
Caoyuan Wang, Master study director
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing The information-based discharge preparation service (IBDPS) in people with Patient Discharge and Infant, Premature, run by The First Affiliated Hospital with Nanjing Medical University.
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 9 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: status not confirmed, as of the sponsor's last update on 26 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caoyuan Wang, Master (+8615062233877, 1621362717@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness for Hospital Discharge Scale (time frame: From enrollment until the preterm infants discharge, with assessments at enrollment, parent entry into the NICU, and discharge,assessed up to 90 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06613386, which also lists 10 linked publications.
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 Sep 2024.