Status:
COMPLETED
Effects of a Valved Feeding System in Late-preterm Newborns: the Safe Oral Feeding Trial
Lead Sponsor:
University of Turin, Italy
Conditions:
Premature Birth
Feeding; Difficult, Newborn
Eligibility:
All Genders
1-5 years
Phase:
NA
Brief Summary
Comparing with a randomized controlled trial two different feeding systems in two groups of late-preterm newborns for evaluating which is more efficient in promoting the coordination in the process of...
Detailed Description
The swallowing patterns are still immature in the newborn, especially if preterm. An incomplete synchronization in the process of sucking, swallowing and breathing could lead to some difficulty during...
Eligibility Criteria
Inclusion
- Gestational age 34+0 - 36+6 weeks at birth;
- Exclusive oral feeding;
- Bottle-feeding for at least a meal a day;
Exclusion
- Newborns with exclusive breastfeeding;
- Newborns with congenital anomalies, perinatal asphyxia, respiratory or neurological issues, genetic syndromes, infections, metabolic diseases;
- Ongoing administration of medication able to interfere with esophageal or respiratory function;
- Newborns who require respiratory support, including oxygen-therapy via nasal-cannula;
- Newborns who require oral or nasal feeding tube;
Key Trial Info
Start Date :
December 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04400175
Start Date
December 1 2020
End Date
May 31 2023
Last Update
August 21 2023
Active Locations (1)
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1
Città della Salute e della Scienza - Ospedale S.Anna - University of Turin
Turin, Italy, 10126