Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06163586
Status:
RECRUITING
Last Update Posted:
2023-12-11
First Post:
2023-11-13
Brief Title:
Infant Massage in the NICU
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Effects of Neonatal Therapeutic Touch and Massage in Very Preterm and Extremely Preterm Neonates A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 about the effects of Neonatal Touch and Massage Therapy on premature babies
The main questions it aims to answer are
Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU
Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain pain and stress responses and neurodevelopmental outcomes
Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU Researchers will compare their outcomes to a control group receiving standard NICU care to see if there are any differences in the length of hospital stay weight gain pain scores neurodevelopmental outcomes and incidence of other common conditions associated with prematurity
The main questions it aims to answer are
Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU
Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain pain and stress responses and neurodevelopmental outcomes
Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU Researchers will compare their outcomes to a control group receiving standard NICU care to see if there are any differences in the length of hospital stay weight gain pain scores neurodevelopmental outcomes and incidence of other common conditions associated with prematurity
Detailed Description:
The purpose of this study is to determine the effects of Neonatal Touch and Massage Therapy on premature infants in the NICU Babies enrolled in this study will be randomly assigned to receive Neonatal Touch and Massage or standard NICU care Babies in the therapy group will be given Neonatal Touch or Massage therapy by certified providers 3 days per week for 5 to 15 minutes Therapy will be done for a minimum of 4 weeks The investigators will assess pain and stress responses before and after treatment The investigators will also review participants medical records to collect information about weight gain length of hospitalization and general health status After a participant is discharged home information will be collected about participants developmental assessments at regularly scheduled NICU follow-up clinic appointments There are no significant risks with this therapy Potential benefits of therapy include increased weight gain shorter hospitalization decreased pain and stress and improved developmental outcomes Information gained from this study could also help future babies
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None