Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06515574
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Effect of Developmental Care on Very Low Birth Weight Infants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Developmental Care on Very Low Birth Weight Infants a Stepped-wedge Cluster Randomised Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Does developmental care shorten the length of hospital stay in the very low birth weight infants
Does developmental care increase the opportunity of family centered care in the very low birth weight infants The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units A developmental care bundle will be tailored to meet the identified needs of participating NICUs
Does developmental care shorten the length of hospital stay in the very low birth weight infants
Does developmental care increase the opportunity of family centered care in the very low birth weight infants The clinical trial will use a 36-month stepped-wedge cluster-randomised trial conducted across 40 Neonatal intensive care units A developmental care bundle will be tailored to meet the identified needs of participating NICUs
Detailed Description:
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 NICUs specific context and needs the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families
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 NICUs specific context and needs the study aims to generate robust evidence on the benefits of developmental care for VLBW infants and their families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None