How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Preterm Birth, Feeding Methods. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
How to Optimize Enteral Feeding of the Full Enteral Feeding Preterm Infant: Evaluation of Different Gastric Tube Management Practices
Overview
Very low-birth-weight premature infants (VLBWs) are fed via nasal or oro-gastric tube for a long time because of the physiological inability to coordinate swallowing, sucking, and breathing until at least 34 weeks of gestational age. Both bolus and continuous feeding modes are widely described in the literature; both modes have specific risks and benefits, and there is no evidence in the literature as to which mode is best in terms of tolerance and adverse effects. To date, the characteristics of enteral feeding that are associated with better feeding tolerance and fewer adverse effects have not been uniquely documented. There are currently no data in the literature directly comparing different modes of enteral feeding tube management in the preterm VLBW infant. Therefore, our study aims to evaluate different modes of enteral feeding tube management (extemporaneous vs. permanent introduction/removal and oral vs. nasal introduction route) in order to optimize enteral feeding management of the VLBW infant.
Detailed description
The purpose of the study is to evaluate the tolerance of intermittent gastric tube placement versus permanent gastric tube maintenance in preterm VLBW infants who have achieved full enteral feeding, and to record the incidence of adverse effects associated with the different modes of gastric tube management.
Specifically, during bolus feeding, the following parameters will be evaluated in association with the two different management modes:
1. Presence, extent and characteristics of episodes of gastric stagnation 2. Incidence of cardio-respiratory events (desaturation and/or bradycardia) 3. Signs and symptoms of pain/discomfort related to the tube insertion and removal procedure In addition, the above parameters will be examined during enteral feeding with an orally or nasally introduced tube.
Primary outcome measures
- Evaluate the tolerance to intermittent gastric tube placement versus permanent gastric tube maintenance in Very Low Birth Weight preterm infants who have achieved full enteral feeding [Time frame: From the 1st patient enrolled, up to 50th patient enrolled]
Eligibility criteria
Inclusion criteria
- Gestational Age <32 weeks and/or neonatal weight <1500 g
- Achievement of full enteral feeding (150 ml/kg/day of milk)
- Exclusive feeding of human milk (breast and/or bank)
- Informed consent signed by parent or legal guardian
Exclusion criteria
- Need for invasive ventilatory support
- Congenital malformations affecting the gastrointestinal tract
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
Italy · 1 center
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
Identifiers
NCT: NCT06760832 · NE_PRE_20