Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06351202
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2024-04-02
Brief Title:
Impact Assessment of Abdominal Massage on Feeding Tolerance of Preterms
Sponsor:
University Hospital Clermont-Ferrand
Organization:
University Hospital Clermont-Ferrand
Study Overview
Official Title:
Impact Assessment of Abdominal Massage on the Feeding Tolerance of Preterms Less Than 34 Weeks of Amenorrhea a Randomized Single-blind Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-01
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:
PREMABDO
Brief Summary:
Every year in France 60000 children are born prematurely before 37 weeks of amenorrhea - WA and present an immaturity of their various systems in particular the digestive system This can result in feeding intolerance expressed by abdominal distension regurgitation irregular transit and abdominal discomfort It can influence the length of hospitalization and lead to necrotising enterocolitis a major complication
At the Clermont-Ferrand University Hospital Center abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective
In this context the investigators carried out a first study to validate a scale that they created ECAP scale Clinical Assessment Scale for Abdominal state of Preterm infant to assess in a rapid reliable and reproductible manner the abdominal state of preterm infant - data currently being published This scale can pose the indications for abdominal massage more objectively
The hypothesis is that abdominal massage improves feeding tolerance decrease ECAP score allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants
The aim of the study is to assess the effectiveness of abdominal massage over a period of 14 days on the feeding tolerance of preterm infants under 34 weeks of amenorrhea defined by the achievement and maintenance of an ECAP score less than 4 during 3 days
At the Clermont-Ferrand University Hospital Center abdominal massages have been performed by physiotherapist for several years in order to improve the state of the digestive system of preterm infants The indication for abdominal massages are very dependent on the caregivers in charge of the newborns because the evaluation of feeding intolerance remains subjective
In this context the investigators carried out a first study to validate a scale that they created ECAP scale Clinical Assessment Scale for Abdominal state of Preterm infant to assess in a rapid reliable and reproductible manner the abdominal state of preterm infant - data currently being published This scale can pose the indications for abdominal massage more objectively
The hypothesis is that abdominal massage improves feeding tolerance decrease ECAP score allows faster weight gain and reaching the full ration and therefore reduces the length of hospitalization of preterm infants
The aim of the study is to assess the effectiveness of abdominal massage over a period of 14 days on the feeding tolerance of preterm infants under 34 weeks of amenorrhea defined by the achievement and maintenance of an ECAP score less than 4 during 3 days
Detailed Description:
This is a single-blind randomized controlled study The children will be recruited in the Neonatal Intensive Care Units of the investigation center by the nursing staff carrying out the ECAP assessment physiotherapists nurses doctors
An information note will be presented and explained by an element of the medical or paramedical staff to the parents After a 24 hours reflexion period and answer to any questions they may have written and informed consent will be requested from both parents for their childs participation in this study
After obtaining the signed consents the randomization will follow In the first group preterm infants with feeding intolerance will not be massed
In the second group at least 10 abdominal massages will be performed by a physiotherapist trained in this technique over a period of 14 days at the rate of one massage per day
Each day the ECAP assessment will be performed at t0min just before performing an abdominal massage in the massed group and at t10min just after performing the massage The investigators estimate that an abdominal massage for premature babies lasts 10 minutes The abdominal massage techniques will be adapted according to the term of the child
An information note will be presented and explained by an element of the medical or paramedical staff to the parents After a 24 hours reflexion period and answer to any questions they may have written and informed consent will be requested from both parents for their childs participation in this study
After obtaining the signed consents the randomization will follow In the first group preterm infants with feeding intolerance will not be massed
In the second group at least 10 abdominal massages will be performed by a physiotherapist trained in this technique over a period of 14 days at the rate of one massage per day
Each day the ECAP assessment will be performed at t0min just before performing an abdominal massage in the massed group and at t10min just after performing the massage The investigators estimate that an abdominal massage for premature babies lasts 10 minutes The abdominal massage techniques will be adapted according to the term of the child
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02256-39 | OTHER | ANSM | None |