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The goal of this clinical trial is to learn if developmental care works when implemented in very low birth weight infants. The main questions it aims to answer are:
Developmental care in the NICU focuses on creating a nurturing environment that supports the physical, emotional, and developmental needs of premature infants. This approach includes strategies like minimizing unnecessary noise and light, ensuring appropriate positioning and handling of infants, promoting skin-to-skin contact, and facilitating parental involvement in care.
The clinical trial investigates the effectiveness of developmental care in very low birth weight (VLBW) infants. The primary objectives are to determine whether developmental care can (1) reduce the length of hospital stay and (2) enhance the opportunity for family-centered care in these infants. The study employs a 36-month stepped-wedge cluster-randomised trial design, involving 40 Neonatal Intensive Care Units (NICUs).
In this trial, all NICUs will eventually receive the intervention, but the order in which they start implementing the developmental care bundle will be randomized. This approach allows each NICU to serve as its own control, comparing outcomes before and after the intervention.
Data collection will occur at multiple time points before and after the implementation of the developmental care bundle, enabling a comprehensive analysis of its impact. By tailoring interventions to each NICU's specific context and needs, the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Developmental care | Experimental | In stage 1, participant in this arm will receive the developmental care |
|
| Usual care | No Intervention | Participant in this arm will receive the usual care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| developmental care | Behavioral | Individualized Developmental Care that includes the light, noise, sleep, etc. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of hospital stay | Length of hospital stay (in days) | From the day admitted into the NICU until day on discharge, generally assessed up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Skin to skin care duration | Skin-to-skin care, also known as kangaroo care, involves placing a newborn baby directly on a parent's bare chest. Record the duration of skin to skin care every day during the hospitalization by hours | From the day admitted into the NICU until day on discharge, generally assessed up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Parental involvement duration | Parental involvement in our study is defined as the parents take part in the daily Care Activities (diapering, bathing, clothing and feeding for their babies).Record the duration of parental involvement every day during the hospitalization by hours | From the day admitted into the NICU until day on discharge, generally assessed up to 1 year |
Inclusion Criteria
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lyu Tianchan | Contact | 18017590870 | lvtianchan1988@aliyun.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's hospital of Fudan university | Recruiting | Shanghai | Shanghai / 上海 | 201102 | China |
Unidentified individual participant data (including data dictionaries) will be made available, in addition to study protocols, the statistical analysis plan, the informed consent form and the related code. The data will be made available upon publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Proposals should be submitted to corresponding authors.
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| Children's Hospital of Fudan University | Not yet recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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