Effect of Tube Feeding on LCPUFAs Delivery

NCT03459209 | Completed

• 1 other identifier: SO-2017-LCPUFA
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lipid Depletion; Human Milk; Tube Feeding

Outcome Measures

Primary Outcomes (1)

• LCPUFA loss

  Reduction in DHA and/or AA contents of each human milk aliquot after tube feeding administration

  3 hours

Interventions

tube feeding OTHER

The obtained milk aliquots undergo in vitro administration through three different tube feeding techniques.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breastfeeding mothers of preterm infants (≤32 weeks gestation) admitted to the Neonatal Intensive Care Unity of Sant'Orsola-Malpighi University Hospital, Bologna (Italy) and human milk donors adhering to the Human Milk Bank of Bologna.

You may qualify if:

• Availability of breast milk
• Stage of lactation: between 2 to 3 months after delivery
• Written, informed consent obtained

You may not qualify if:

• breast milk not available
• \<2 months or \>3 months from delivery
• no consent obtained

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital

Bologna, 40138, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human milk samples (17 specimens)

MeSH Terms

Interventions

Enteral Nutrition

Intervention Hierarchy (Ancestors)

Feeding Methods; Therapeutics; Nutritional Support; Nutrition Therapy

Study Officials

• Luigi Corvaglia, MD

  Sant'Orsola-Malpighi University Hospital, Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 3, 2018
• First Posted: March 8, 2018
• Study Start: April 1, 2016
• Primary Completion: March 31, 2017
• Study Completion: April 30, 2017
• Last Updated: May 14, 2019

Record last verified: 2019-05

Locations

IT (1)