Effects of nutrition therapy on growth, inflammation and metabolism in immature infants: a study protocol of a double-blind randomized controlled trial (ImNuT).
Arachidonic acid
Brain maturation
Docosahexaenoic acid
Inflammation
Nutrition
Preterm
Journal
BMC pediatrics
ISSN: 1471-2431
Titre abrégé: BMC Pediatr
Pays: England
ID NLM: 100967804
Informations de publication
Date de publication:
07 01 2021
07 01 2021
Historique:
received:
14
08
2020
accepted:
10
11
2020
entrez:
7
1
2021
pubmed:
8
1
2021
medline:
28
5
2021
Statut:
epublish
Résumé
Current nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation. Infants born at Oslo University Hospital are eligible to participate in this double-blind randomized controlled trial. Study participants are randomized to receive an enteral FA supplement of either 0.4 ml/kg MCT-oil™ (medium chain triglycerides) or 0.4 ml/kg Formulaid™ (100 mg/kg of ARA and 50 mg/kg of DHA). The FA supplement is given from the second day of life to 36 weeks' postmenstrual age (PMA). The primary outcome is brain maturation assessed by Magnetic Resonance Imaging (MRI) at term equivalent age. Secondary outcomes include quality of growth, incidence of neonatal morbidities, cardiovascular health and neuro-development. Target sample size is 120 infants (60 per group), this will provide 80% power to detect a 0.04 difference in mean diffusivity (MD, mm Supplementation of ARA and DHA has the potential to improve brain maturation and reduce inflammation related diseases. This study is expected to provide valuable information for future nutritional guidelines for preterm infants. Clinicaltrials.gov ID: NCT03555019 . Registered 4 October 2018- Retrospectively registered.
Sections du résumé
BACKGROUND
Current nutritional management of infants born very preterm results in significant deficiency of the essential fatty acids (FAs) arachidonic acid (ARA) and docosahexaenoic acid (DHA). The impact of this deficit on brain maturation and inflammation mediated neonatal morbidities are unknown. The aim of this study is to determine whether early supply of ARA and DHA improves brain maturation and neonatal outcomes in infants born before 29 weeks of gestation.
METHODS
Infants born at Oslo University Hospital are eligible to participate in this double-blind randomized controlled trial. Study participants are randomized to receive an enteral FA supplement of either 0.4 ml/kg MCT-oil™ (medium chain triglycerides) or 0.4 ml/kg Formulaid™ (100 mg/kg of ARA and 50 mg/kg of DHA). The FA supplement is given from the second day of life to 36 weeks' postmenstrual age (PMA). The primary outcome is brain maturation assessed by Magnetic Resonance Imaging (MRI) at term equivalent age. Secondary outcomes include quality of growth, incidence of neonatal morbidities, cardiovascular health and neuro-development. Target sample size is 120 infants (60 per group), this will provide 80% power to detect a 0.04 difference in mean diffusivity (MD, mm
DISCUSSION
Supplementation of ARA and DHA has the potential to improve brain maturation and reduce inflammation related diseases. This study is expected to provide valuable information for future nutritional guidelines for preterm infants.
TRIAL REGISTRATION
Clinicaltrials.gov ID: NCT03555019 . Registered 4 October 2018- Retrospectively registered.
Identifiants
pubmed: 33407269
doi: 10.1186/s12887-020-02425-x
pii: 10.1186/s12887-020-02425-x
pmc: PMC7789285
doi:
Substances chimiques
Docosahexaenoic Acids
25167-62-8
Arachidonic Acid
27YG812J1I
Banques de données
ClinicalTrials.gov
['NCT03555019']
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
19Subventions
Organisme : Norges Forskningsråd
ID : 260552/h10
Investigateurs
Marlen Fossan Aas
(MF)
Mona Kristiansen Beyer
(MK)
Jens-Petter Berg
(JP)
Marianne Bratlie
(M)
Atle Bjornerud
(A)
Maninder Singh Chawla
(MS)
Siw Helen Westby Eger
(SHW)
Cathrine Nygaard Espeland
(CN)
Oliver Geier
(O)
Gunnthorunn Gunnarsdottir
(G)
Christina Henriksen
(C)
Per Kristian Hol
(PK)
Henrik Holmstrøm
(H)
Ivan Maximov
(I)
Tone Nordvik
(T)
Madelaine Eloranta Rossholt
(ME)
Helene Caroline Dale Osterholt
(HCD)
Ingjerd Saeves
(I)
Elin Blakstad
(E)
Henriette Astrup
(H)
Helge Froisland
(H)
Lars Tveiten
(L)
Krzysztof Hochnowski
(K)
Terje Reidar Selberg
(TR)
Henning Hoyte
(H)
Randi Borghild Stornes
(RB)
Hanne Isdal
(H)
Thea Wauters Thyness
(TW)
Petra Huppi
(P)
Alexandre Lapillonne
(A)
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