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Lipid DepletionNCT03459209

Effect of Tube Feeding on LCPUFAs Delivery

An observational study of Lipid Depletion and Human Milk, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Lipid Depletion, Human Milk, Tube Feeding
What is being tested?
tube feeding
How many people
10 participants
Where
1 siteItaly
Study dates
1 Apr 2016to 30 Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Neonatal Intensive Care Unit, S.Orsola-Malpighi Hospital

    Bologna, 40138

Other trials in Italy

About this study

Official title: Effect of Different Tube-feeding Techniques on the Delivery of Human Milk Long-chain Polyunsaturated Fatty Acids

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.

Read the detailed description

Despite recent improvements in neonatal care, the delicate extra-uterine maturation of central nervous system place preterm infants at high risk for neurodevelopmental impairment.

Long-chain polyunsaturated fatty acids (LCPUFAs) docosahexaenoic (DHA, 22:6 n-3) and arachidonic acid (AA, 20:4 n-6) are major building blocks for the lipid bilayer of neuronal and retinal membranes, thus playing a crucial role in brain and visual development. Humans, however, lack enzymes for synthetizing n-3 and n-6 precursors of DHA and AA, thus strictly relying upon dietary sources. Human milk (HM) feeding, either own mother's milk (OMM) or donor milk (DM), is the first nutritional choice for preterm infants and, if maternal dietary intakes are adequate, is expected to provide appropriate LCPUFAs amounts in this fragile population. Nevertheless, in addition to the type of milk, equal attention should be paid to its delivery methods.

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 the effect of different TF techniques routinely adopted for preterm infants' enteral nutrition on DHA and AA delivery.

Mothers of preterm infants (≤32 weeks' gestation) admitted to the Neonatal Intensive Care Unity of Sant'Orsola-Malpighi University Hospital, Bologna (Italy), and HM donors adhering to the Human Milk Bank of Bologna will be enrolled in the present study if written, informed consent to participate will be obtained.

Samples of fresh human milk or pasteurized donor milk, each one of 65 ml, will be collected. These samples will be then split into three 20-ml aliquots that will be subjected to as many TF modalities, whereas the remaining 5 ml will serve as baseline.

By using a 20-ml polypropylene syringe connected to a feeding tube, three different TF modalities will be simulated at room temperature conditions: gravity bolus feeding (BF), horizontal continuous feeding (HCF) and 45-degree-angled continuous feeding (ACF).

HCF and ACF will be delivered over 3 hours. During HCF the feeding syringe will be horizontal, whereas during ACF the tip of the feeding syringe will be angled 45° upward from the longitudinal axis. Moreover, in order to evaluate the efficacy of lipid delivery in relation to different phases of continuous feeding, HM delivered from 0 to 90 min and from 91 to 180 min will be collected and analyzed separately.

Eventually, LCPUFAs contents in the resulting specimens will be analyzed by means of gas chromatography coupled to mass spectrometry (GC-MS) at the laboratory of the Center for Applied Biomedical Research (CRBA) of S. Orsola-Malpighi University Hospital in Bologna, Italy.

Being tested
tube feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tube feedingOther

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LCPUFA loss

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

    Measured: 3 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start1 Apr 2016
  3. Primary completion31 Mar 2017
  4. Study completion30 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03459209
Sponsor's protocol ID
SO-2017-LCPUFA
Status last verified
May 2019
First submitted
3 Mar 2018
Last updated
14 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Lipid Depletion and Human Milk, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LCPUFA loss (time frame: 3 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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