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Visual outcome at 2.5 years of age in ω-3 and ω-6 long-chain polyunsaturated fatty acid supplemented preterm infants : a follow-up of a randomized controlled trial

Lundgren, Pia ; Jacobson, Lena ; Gränse, Lotta LU orcid ; Hård, Anna-Lena ; Sävman, Karin ; Hansen-Pupp, Ingrid LU orcid ; Ley, David LU ; Nilsson, Anders K ; Pivodic, Aldina and Smith, Lois E , et al. (2023) In The Lancet regional health. Europe 32. p.1-9
Abstract

BACKGROUND: We investigated ophthalmological outcomes at 2.5 years of corrected age in children born extremely preterm (EPT) to evaluate the effects of postnatal enteral supplementation with ω-3 and ω-6 long-chain polyunsaturated fatty acids.

METHODS: In the Mega Donna Mega clinical trial, EPT infants born at less than 28 weeks of gestation were randomized to receive an enteral supplementation of docosahexaenoic acid (DHA) and arachidonic acid (AA) from birth to 40 weeks postmenstrual age. In this exploratory follow-up at 2.5 years of corrected age, we assessed visual acuity (VA), refraction, manifest strabismus, and nystagmus. Satisfactory VA was defined as ≥20/63. Multiple imputation (MI) was used to address the issue of missing... (More)

BACKGROUND: We investigated ophthalmological outcomes at 2.5 years of corrected age in children born extremely preterm (EPT) to evaluate the effects of postnatal enteral supplementation with ω-3 and ω-6 long-chain polyunsaturated fatty acids.

METHODS: In the Mega Donna Mega clinical trial, EPT infants born at less than 28 weeks of gestation were randomized to receive an enteral supplementation of docosahexaenoic acid (DHA) and arachidonic acid (AA) from birth to 40 weeks postmenstrual age. In this exploratory follow-up at 2.5 years of corrected age, we assessed visual acuity (VA), refraction, manifest strabismus, and nystagmus. Satisfactory VA was defined as ≥20/63. Multiple imputation (MI) was used to address the issue of missing data.

FINDINGS: Of 178 children in the trial, 115 (with median gestational age (GA) of 25 + 4/7 weeks and median birth weights of 790 g) were ophthalmologically assessed at a median corrected age of 2.7 years (range 2.0-3.9 years). VA assessment was missing in 42.1% (75/178), in 41.7% (35/84) of the AA/DHA supplemented infants, and in 42.6% (40/94) of the control infants. After MI and adjustments for GA, study center, plurality, and corrected age at VA exam, no significant effect of AA/DHA supplementation was detected in VA outcome (≥20/63) (odds ratio 2.16, confidence interval 95% 0.99-4.69, p = 0.053).

INTERPRETATION: In this randomized controlled trial follow-up, postnatal supplementation with enteral AA/DHA to EPT children did not significantly alter VA at 2.5 years of corrected age. Due to the high loss to follow-up rate and the limited statistical power, additional studies are needed.

FUNDING: The Swedish Medical Research Council #2020-01092, The Gothenburg Medical Society, Government grants under the ALF agreement ALFGBG-717971 and ALFGBG-971188, De Blindas Vänner, Knut and Alice Wallenberg Foundation - Wallenberg Clinical Scholars, NIHEY017017, EY030904BCHIDDRC (1U54HD090255 Massachusetts Lions Eye Foundation) supported the study.

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publishing date
type
Contribution to journal
publication status
published
subject
in
The Lancet regional health. Europe
volume
32
article number
100696
pages
1 - 9
publisher
Elsevier
external identifiers
  • pmid:37671123
  • scopus:85169467404
ISSN
2666-7762
DOI
10.1016/j.lanepe.2023.100696
language
English
LU publication?
yes
additional info
© 2023 The Author(s).
id
d59a2483-cb03-48a7-85f1-472a5ac5d613
date added to LUP
2023-10-19 12:11:19
date last changed
2024-02-18 21:03:28
@article{d59a2483-cb03-48a7-85f1-472a5ac5d613,
  abstract     = {{<p>BACKGROUND: We investigated ophthalmological outcomes at 2.5 years of corrected age in children born extremely preterm (EPT) to evaluate the effects of postnatal enteral supplementation with ω-3 and ω-6 long-chain polyunsaturated fatty acids.</p><p>METHODS: In the Mega Donna Mega clinical trial, EPT infants born at less than 28 weeks of gestation were randomized to receive an enteral supplementation of docosahexaenoic acid (DHA) and arachidonic acid (AA) from birth to 40 weeks postmenstrual age. In this exploratory follow-up at 2.5 years of corrected age, we assessed visual acuity (VA), refraction, manifest strabismus, and nystagmus. Satisfactory VA was defined as ≥20/63. Multiple imputation (MI) was used to address the issue of missing data.</p><p>FINDINGS: Of 178 children in the trial, 115 (with median gestational age (GA) of 25 + 4/7 weeks and median birth weights of 790 g) were ophthalmologically assessed at a median corrected age of 2.7 years (range 2.0-3.9 years). VA assessment was missing in 42.1% (75/178), in 41.7% (35/84) of the AA/DHA supplemented infants, and in 42.6% (40/94) of the control infants. After MI and adjustments for GA, study center, plurality, and corrected age at VA exam, no significant effect of AA/DHA supplementation was detected in VA outcome (≥20/63) (odds ratio 2.16, confidence interval 95% 0.99-4.69, p = 0.053).</p><p>INTERPRETATION: In this randomized controlled trial follow-up, postnatal supplementation with enteral AA/DHA to EPT children did not significantly alter VA at 2.5 years of corrected age. Due to the high loss to follow-up rate and the limited statistical power, additional studies are needed.</p><p>FUNDING: The Swedish Medical Research Council #2020-01092, The Gothenburg Medical Society, Government grants under the ALF agreement ALFGBG-717971 and ALFGBG-971188, De Blindas Vänner, Knut and Alice Wallenberg Foundation - Wallenberg Clinical Scholars, NIHEY017017, EY030904BCHIDDRC (1U54HD090255 Massachusetts Lions Eye Foundation) supported the study.</p>}},
  author       = {{Lundgren, Pia and Jacobson, Lena and Gränse, Lotta and Hård, Anna-Lena and Sävman, Karin and Hansen-Pupp, Ingrid and Ley, David and Nilsson, Anders K and Pivodic, Aldina and Smith, Lois E and Hellström, Ann}},
  issn         = {{2666-7762}},
  language     = {{eng}},
  pages        = {{1--9}},
  publisher    = {{Elsevier}},
  series       = {{The Lancet regional health. Europe}},
  title        = {{Visual outcome at 2.5 years of age in ω-3 and ω-6 long-chain polyunsaturated fatty acid supplemented preterm infants : a follow-up of a randomized controlled trial}},
  url          = {{http://dx.doi.org/10.1016/j.lanepe.2023.100696}},
  doi          = {{10.1016/j.lanepe.2023.100696}},
  volume       = {{32}},
  year         = {{2023}},
}