NCT05989009

Brief Summary

Various studies have shown that the milk of a preterm infant differs from that of a term infant in the composition of micronutrients, vitamins, macronutrients, carbohydrates and proteins. The study of lipidomic is of particular interest because the role of fatty acids is known both as essential constituents of cell membranes and as molecules actively involved in energy metabolism. The study of human milk would offer the advantage of offering the best type of nutrition for the newborn at each specific period of life, in the event of a lack of mother's milk.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2022

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2023

Enrollment Period

1.6 years

First QC Date

August 3, 2023

Last Update Submit

September 4, 2024

Conditions

Breast Milk Collection

Keywords

newbornbreast milkfatty acidgestational age

Outcome Measures

Primary Outcomes (5)

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    To assess the concentrations of α-Linoleic acid (µg/mL) in human milk

    7 days after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    To assess the concentrations of Eicosapentaenoic acid (µg/mL) in human milk

    7 days after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    To assess the concentrations of Docosahexaenoic acid (µg/mL) in human milk

    7 days after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    To assess the concentrations of Arachidonic acid (µg/mL) in human milk

    7 days after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    To assess the concentrations of Linoleic acid (µg/mL) in human milk

    7 days after delivery

Secondary Outcomes (5)

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    1 month after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    1 month after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    1 month after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    1 month after delivery

  • Quantification of essential long-chain polyunsaturated fatty acids in human milk

    1 month after delivery

Study Arms (3)

Women < 32 weeks of gestational age

Women that delivered before 32 weeks of gestational age

Other: Breastfeeding

Women between 32 and 36,6 weeks of gestational age

Women that delivered between 32 and 36,6 weeks of gestational age

Other: Breastfeeding

Women > 37 weeks of gestational age

Women that delivered after 37 weeks of gestational age

Other: Breastfeeding

Interventions

BreastfeedingOTHER

Mothers will breastfeed their newborns

Women < 32 weeks of gestational ageWomen > 37 weeks of gestational ageWomen between 32 and 36,6 weeks of gestational age

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

They were enrolled mothers that delivered at Buon Consiglio Fatebenefratelli Hospital, Napoli

You may qualify if:

  • Mothers who have given birth in hospital at any gestational age
  • Written informed consent
  • BMI 18.50-24.99 Kg/m2
  • Varied and balanced maternal diet without restrictions
  • Weight gain during pregnancy up to 12kg

You may not qualify if:

  • Food intolerance
  • Celiac disease
  • Vegan or vegetarian diet
  • Diagnosis of metabolic diseases
  • Taking medicines during pregnancy
  • Withdrawal of informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Pharmacy, University of Salerno

Salerno, Naples, 84084, Italy

Location

Department of Woman and Child, Buon Consiglio Fatebenefratelli Hospital

Napoli, Napoli, 80123, Italy

Location

MeSH Terms

Conditions

Breast Milk Expression

Interventions

Lactation

Condition Hierarchy (Ancestors)

Breast FeedingFeeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Reproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaPostpartum Period

Study Officials

  • Giuseppe De Bernardo, MD

    Ospedale Buon Consiglio Fatebenefratelli

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department of Woman and Child

Study Record Dates

First Submitted

August 3, 2023

First Posted

August 14, 2023

Study Start

March 1, 2022

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

September 19, 2024

Record last verified: 2023-08

Locations

IT(2)