Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06273202
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-02-09
Brief Title:
Ultrasound Monitoring of Muscle Thickness in Premature Patients
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Ultrasound Monitoring of Muscle Thickness in Premature Patients Undergoing Infant Massage Experience in a Neonatal Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2024-05
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:
NeoMassage
Brief Summary:
The goal of this interventional study is to investigate through musculoskeletal ultrasonography how the thickness and muscle trophism in infants aged 28 to 35 weeks undergoing infant massage compared with a group of infants with similar characteristics not subjected to treatment
The main questions it aims to answer are
To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle Specifically changes in muscle thickness and trophism of the quadriceps femoris
Potential effects on spontaneous motility and stature-ponderal growth of infants In addition the discomfort and behavioral status of the infant before and after massage will be investigated infant
Patients included in the study will be randomized according to a random sequence with a 11 ratio into theexperimental group GS or the control group GC Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative to which patients in the control group will be subjected exclusively control
Infant massage will be performed three times a day 10 minutes per session until they reach the 35th week of post-conceptional age 356 by the two departmental physical therapists ADP and ADV
Ultrasound will be performed at the time of randomization T0 and then 1 time per week until the 35th week by two operators SN and VA at the same time the circumference of the thigh subjected to ultrasound examination A 12Hz linear ultrasound probe will be used applied perpendicular to the skin The infant will be placed supine with the thigh extended in a neutral position excessive compression will be avoided by applying a generous amount of gel At the midpoint of the thigh the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia The average of at least 2 measurements will be then calculated The Heckmatt scale will be used to assess the echogenicity of muscle and bone In addition at time T0 and at week 35 the following data will be collected weeks gestational age weight at birth and at the end of treatment rectal temperature blood gas parameters if present
The main questions it aims to answer are
To assess by musculoskeletal ultrasound the impact of infant massage on muscle thickness muscle Specifically changes in muscle thickness and trophism of the quadriceps femoris
Potential effects on spontaneous motility and stature-ponderal growth of infants In addition the discomfort and behavioral status of the infant before and after massage will be investigated infant
Patients included in the study will be randomized according to a random sequence with a 11 ratio into theexperimental group GS or the control group GC Patients in the GS will perform therapy with infant massage in addition to the usual rehabilitation therapies as specified by the program individual habilitative to which patients in the control group will be subjected exclusively control
Infant massage will be performed three times a day 10 minutes per session until they reach the 35th week of post-conceptional age 356 by the two departmental physical therapists ADP and ADV
Ultrasound will be performed at the time of randomization T0 and then 1 time per week until the 35th week by two operators SN and VA at the same time the circumference of the thigh subjected to ultrasound examination A 12Hz linear ultrasound probe will be used applied perpendicular to the skin The infant will be placed supine with the thigh extended in a neutral position excessive compression will be avoided by applying a generous amount of gel At the midpoint of the thigh the thickness of the quadriceps muscle will be calculated by measuring the distance between the cortex of the femur and the most superficial muscle fascia The average of at least 2 measurements will be then calculated The Heckmatt scale will be used to assess the echogenicity of muscle and bone In addition at time T0 and at week 35 the following data will be collected weeks gestational age weight at birth and at the end of treatment rectal temperature blood gas parameters if present
Detailed Description:
None
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