Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-31 @ 12:04 PM
Study NCT ID:
NCT03016767
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2016-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of an Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Sponsor:
Fundacion Para La Investigacion Hospital La Fe
Organization:
Study Overview
Official Title:
Efficacy of a Manual Oral Stimulation Protocol in Preterm Infants to Shorten the Period Between Enteral and Oral Nutrition
Status:
COMPLETED
Status Verified Date:
2018-10
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:
Oral feeding in the neonatal period requires an accurate coordination between suction, swallowing and breathing. In premature new-borns and, depending on their gestational age, the coordinated work of those processes becomes jeopardised, being necessary to begin with an artificial enteral feeding. This situation results in lengthen their stay at the hospital until they are able to respond in a reliable way to their nutritional requirements orally, maintaining an adequate daily weight gain and without endangering their cardiorespiratory system.
This project is an experimental, prospective, blinded, randomized study, aimed to determine whether the application of a manual oral stimulation protocol in premature infants, hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral full feeding, while improves quality of feeding and shortens hospitalization time.
This project is an experimental, prospective, blinded, randomized study, aimed to determine whether the application of a manual oral stimulation protocol in premature infants, hospitalized in a neonatal unit, reduces the transition time from enteral feeding to oral full feeding, while improves quality of feeding and shortens hospitalization time.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: