Enteral Supplementation With Docosahexaenoic Acid and Arachidonic Acid (DHA-AA) in Preterm Infants

NCT06366893 | Recruiting

• 1 other identifier: PR(AG)297/2019
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Docosahexaenoic acid (DHA) and arachidonic acid (AA) have a critical effect on the health and neuronal development of the fetus and newborn. Their deficiency has been associated with increased neonatal morbidity, especially in preterm newborns at birth. Direct DHA supplementation during the first few weeks of life could prevent this deficiency. The aim is to increase DHA levels in the red blood cell membrane while maintaining the fetal proportion to AA in preterm infants through enteral administration of DHA/AA in a safe, tolerated, and effective manner. This approach aims to avoid the decline in DHA/AA levels and the consequences of their deficiency. The study is a single-center, prospective, randomized, controlled, open-label study involving preterm infants admitted to the Neonatology Department of Vall d'Hebron University Hospital in Barcelona.

Conditions

Infant, Premature, Diseases

Keywords

docosahexaenoic acid; arachidonic acid; erythrocyte membrane; preterm infants; supplementation

Outcome Measures

Primary Outcomes (1)

• Percentage comparison of erythrocyte membrane levels of DHA and AA

  Compare the percentage erythrocyte membrane levels of DHA and AA during the first month of life between the supplemented group and the control group.

  4 weeks

Secondary Outcomes (2)

• Tolerance of DHA emulsion administration

  4 weeks

• Compare the presence of pathologies in preterm infants between the supplemented group and the control group

  4 weeks

Study Arms (2)

Study group

EXPERIMENTAL

The study group will be supplemented with DHA and AA emulsion for 28 days. Patients will be followed up until hospital discharge. The emulsion will be administered by nasogastric or orogastric tube together with the scheduled milk intake (from the bank or the mother's own with a differentiated amount of supplementation depending on the type of milk administered and the infant's weight).

Dietary Supplement: DHA/AA emulsion supplement for preterm infant

Control group

NO INTERVENTION

The control group will not be supplemented with DHA and AA emulsion. Patients will be followed up until hospital discharge.

Interventions

DHA/AA emulsion supplement for preterm infant DIETARY_SUPPLEMENT

Enteral supplementation of DHA/AA emulsion

Study group

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Newborns with a gestational age between 23 and 32 weeks admitted to the Neonatology Service of the Vall d'Hebron University Hospital and with informed consent signed by the parents or legal guardians.

You may not qualify if:

• Severe malformation incompatible with life.
• Impossibility of enteral nutrition during the expected duration of the study (30 days).

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Materno Infantil Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (2)

• Castillo Salinas F, Montaner Ramon A, Castillo Ferrer FJ, Domingo-Carnice A, Cordobilla B, Domingo JC. Erythrocyte Membrane Docosahexaenoic Acid (DHA) and Lipid Profile in Preterm Infants at Birth and Over the First Month of Life: A Comparative Study with Infants at Term. Nutrients. 2022 Nov 22;14(23):4956. doi: 10.3390/nu14234956.

  PMID: 36500985 BACKGROUND

• Castillo F, Castillo-Ferrer FJ, Cordobilla B, Domingo JC. Inadequate Content of Docosahexaenoic Acid (DHA) of Donor Human Milk for Feeding Preterm Infants: A Comparison with Mother's Own Milk at Different Stages of Lactation. Nutrients. 2021 Apr 15;13(4):1300. doi: 10.3390/nu13041300.

  PMID: 33920807 BACKGROUND

MeSH Terms

Conditions

Infant, Premature, Diseases

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Félix Castillo Salinas, Dr.

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Félix Castillo Salinas, Dr.

CONTACT

+34934893899; felix.castillo@vallhebron.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: April 16, 2024
• Study Start: March 4, 2024
• Primary Completion: March 4, 2025
• Study Completion: March 4, 2025
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)