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NCT03459209
Effect of Tube Feeding on LCPUFAs Delivery
trial testing tube feeding in Lipid Depletion in 10 participants. Completed in 30 April 2017.
31 March 2017
Quick facts
| Lead sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 10 |
| Start date | 1 April 2016 |
| Primary completion | 31 March 2017 |
| Estimated completion | 30 April 2017 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- tube feeding
Conditions studied
- Lipid Depletion — all drugs for Lipid Depletion →
- Human Milk — all drugs for Human Milk →
- Tube Feeding — all drugs for Tube Feeding →
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna — full company profile →
Who can join
18 and older, female only, with Lipid Depletion or Human Milk. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic (DHA) arachidonic acid (AA) are major building blocks for the lipid bilayer of neuronal and retinal membranes and play a crucial role in brain and visual development. Humans lack enzymes synthetizing DHA and AA precursors and thus rely upon dietary sources to achieve adequate intakes. Human milk (HM) feeding, either own mother's milk (OMM) or donor milk (DM), is the first nutritional choice for preterm infants and provides appropriate LCPUFAs amounts to support neurological and visual development of this fragile population. Due to their immaturity, preterm infants are often unable to coordinate sucking and swallowing, thus requiring tube feeding (TF) for prolonged time periods. During TF, fatty acids tend to separate from aqueous milk components and to adhere to the infusion set, thus reducing the delivery of HM lipid contents. To dare, however, a targeted evaluation of TF-related LCPUFAs losses has not been performed. This study aims to quantitatively assess, by means of gas chromatography coupled to mass spectrometry, the effect of bolus and different continuous feeding methods routinely adopted for preterm infants' enteral nutrition on the delivery of DHA and AA contained in human milk samples.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03459209 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Last refreshed: 14 May 2019
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