Evidence map›Paper›PMID 33836708›Full record

ArticleBMC pediatrics2021

Targeting human milk fortification to improve very preterm infant growth and brain development: study protocol for Nourish, a single-center randomized, controlled clinical trial.

Mandy B Belfort, Lianne J Woodward, Sara Cherkerzian, Hunter Pepin, Deirdre Ellard, Tina Steele, Christoph Fusch, P Ellen Grant, Terrie E Inder

Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC pediatrics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03977259 (Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
1.4field-weighted citation impact, top 21% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03977259 naactive not recruitingnot on this map

Targeting Human Milk Fortification to Improve Preterm Infant Growth and Brain Development

TypeinterventionalSponsorBrigham and Women's HospitalRan2020 to 2030Enrolled130ConditionsPreterm Birth, Breast Milk Expression, Nutrition Disorder, Infant, Brain Development AbnormalityArmsIndividually targeted fortification
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 15 citations in OpenAlex.

  1. Trial
  2. Observational
  3. Article
  4. Observational
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  6. Review
  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 4 institutions in 3 countries.

Mandy B BelfortDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA. mbelfort@bwh.harvard.edu.ORCID 0000-0001-8799-3313
Lianne J WoodwardSchool of Health Sciences and Child Wellbeing Research Institute, University of Canterbury, Christchurch, New Zealand.
Sara CherkerzianDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.
Hunter PepinDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.
Deirdre EllardDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.
Tina SteeleDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.
Christoph FuschDepartment of Pediatrics, Paracelsus Medical School, Nuremberg, Germany.
P Ellen GrantHarvard Medical School, Boston, MA, USA.
Terrie E InderDepartment of Pediatric Newborn Medicine, Brigham and Women's Hospital, 221 Longwood Avenue, BL-341, Boston, MA, 02115, USA.
Brigham and Women's Hospital · USBoston Children's Hospital · USParacelsus Medizinische Privatuniversität · DEUniversity of Canterbury · NZ

Funding

Targeting human milk fortification to improve preterm infant growth and brain developmentR01HD097327 · NICHD · BRIGHAM AND WOMEN'S HOSPITAL · PI BELFORT, MANDY BROWN · 2019 to 2023
$3.8M
NICHD NIH HHS R01 HD097327
6 · The paper itself

Abstract

backgroundHuman milk is recommended for very preterm infants, but its variable macronutrient content may contribute to undernutrition during a critical period in development. We hypothesize that individually targeted human milk fortification is more effective in meeting macronutrient requirements than the current standard of care.

methodsWe designed a single-center randomized, controlled trial enrolling 130 infants born < 31 completed weeks' gestation. Participants will receive fortified maternal and/or pasteurized donor milk but no formula. For participants in the intervention group, milk will be individually fortified with protein and fat modulars to achieve target levels based on daily point-of-care milk analysis with mid-infrared spectroscopy, in addition to standard fortification. The study diet will continue through 36 weeks' postmenstrual age (PMA). Clinical staff and parents will be masked to study group. Primary outcomes include: 1) body length and lean body mass by air displacement plethysmography at 36 weeks' PMA; 2) quantitative magnetic resonance imaging-based measures of brain size and microstructure at term equivalent age; and 3) Bayley-IV scales at 2 years' corrected age. DISCUSSION: We expect this trial to provide important data regarding the effectiveness of individually targeted human milk fortification in the neonatal intensive care unit (NICU).

trial registrationNCT03977259 , registered 6 June, 2019.

Indexed as

Infant, PrematureMilk, HumanBrainChild, PreschoolFood, FortifiedHumansInfantInfant, NewbornInfant Nutritional Physiological PhenomenaInfant, Very Low Birth WeightIntensive Care Units, NeonatalRandomized Controlled Trials as TopicGrowthHuman milkMagnetic resonance imagingNeonatal intensive careNeurodevelopmentNutritionRandomized trialVery preterm infant

Identifiers

PMID33836708
PMCPMC8033746
OpenAlexW3139737475

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.