scholarly journals The “Fortilat” Randomized Clinical Trial Follow-Up: Neurodevelopmental Outcome at 18 Months of Age

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3807
Author(s):  
Chiara Peila ◽  
Elena Spada ◽  
Sonia Deantoni ◽  
Ester Iuliano ◽  
Guido E. Moro ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Milk ◽  
Preterm Infants ◽  
Bovine Milk ◽  
Wilcoxon Test ◽  
Protein Supplement ◽  
Donkey Milk ◽  
Neurodevelopmental Outcomes

Adequate nutrition is fundamental to neonatal survival and short-term outcomes, but it also has long-term consequences on quality of life and neurologic development of preterm infants. Donkey milk has been suggested as a valid alternative for children allergic to cows’ milk proteins, due to its biochemical similarity to human milk; we, hence, hypothesized that donkey milk could be a suitable basis for developing an innovative human milk fortifier for feeding preterm infants. The aim of the current study was to extend the findings and to evaluate the neurodevelopmental outcomes at 18 months of corrected age of the infants enrolled in the clinical trial named “Fortilat”. Infants born ≤1500 g and <32 weeks of gestational age were randomized to receive either a combination of bovine milk-based multicomponent fortifier and protein supplement or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The followed fortification protocol was the same for the two groups and the two diets were designed to be isoproteic and isocaloric. All infants enrolled were included in a developmental assessment program. The neurodevelopmental assessment was performed at 18 ± 6 months of corrected age. Minor and major neurodevelopmental impairment and General Quotient (GQ) at the Griffiths-II Mental Development Scale were considered. The GQ was considered both in continuous and as two classes: lower than and higher than (or equal to) a defined cutoff (GQcl). The difference in GQ and GQcl between the two arms was estimated using Mann–Whitney–Wilcoxon test or Fischer exact test, respectively, on the assumption of casual loss at follow-up. A further analysis was performed using generalized linear models. There were 103 children (bovine milk-derived fortifier arm = 54, donkey milk-derived fortifier arm = 49) included for the neurodevelopmental follow-up. All observations were included in the interval of 18 ± 6 months of corrected age. No significant difference was observed between the two arms in the incidence of neurologic sequelae and the GQs were similar in the two arms. Our results demonstrated no difference for the donkey milk-derived fortifier compared to standard bovine-derived fortifier regarding long-term neurodevelopmental outcomes.

scholarly journals The “Fortilat” Randomized Clinical Trial Follow-Up: Auxological Outcome at 18 Months of Age

Nutrients ◽  
2020 ◽  
Vol 12 (12) ◽  
pp. 3730
Author(s):  
Chiara Peila ◽  
Elena Spada ◽  
Enrico Bertino ◽  
Sonia Deantoni ◽  
Federica Percivati ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Milk ◽  
Preterm Infants ◽  
Head Circumference ◽  
Donkey Milk ◽  
Postmenstrual Age ◽  
Hospital Visits ◽  
Feeding Tolerance

Human milk fortification is a routine clinical practice for feeding preterm infants. We hypothesized that donkey milk can be a suitable basis for developing an innovative human milk fortifier. Our randomized controlled single-blind clinical trial, named “Fortilat”, evaluated the feeding tolerance, growth and clinical short-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk. The aim of the current study is to extend the previous findings and to evaluate the auxological outcomes of the infants enrolled in the “Fortilat” trial at 18 months of age. In the previous trial “Fortilat”, the fortification protocol followed was the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. All infants enrolled in the trial were included in a premature infant developmental evaluation program consisting of hospital visits at 40 ± 1 weeks of postmenstrual age, and at 6, 12 and 18 months of corrected age. Weight, head circumference and length were expressed in z-score using neonatal Intergrowth21st and INeS charts at birth, and WHO 0–5 years growth charts at 18 months. 122 children (Bovine-arm = 62, Donkey-arm = 60) were included in this study. All the observations were recorded in the interval of 18 ± 3 months of the correct age. The two groups did not differ for head circumference, length or weight at 18 months of age. Our data show that fortifiers derived from donkey milk had not different long term auxological outcomes of standard bovine-derived fortifier, but the new donkey milk fortifier was well tolerated in our population.

scholarly journals Nutrient Enrichment of Human Milk with Human and Bovine Milk-Based Fortifiers for Infants Born <1250 g: 18-month Neurodevelopment Follow-up of a Randomized Clinical Trial

2019 ◽  
Author(s):  
Kathryn E Hopperton ◽  
Deborah L O'Connor ◽  
Nicole Bando ◽  
Aisling M Conway ◽  
Dawn V Y Ng ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Human Milk ◽  
Randomized Clinical Trial ◽  
Bovine Milk ◽  
Mean Difference ◽  
Donor Milk ◽  
Mother's Milk ◽  
Adjusted Scores ◽  
Composite Scores

Abstract Background Bovine milk-based fortifiers (BMBF) have been standard of care for nutrient fortification of feeds for very low birthweight (VLBW) infants, however there is increasing use of human milk-based fortifiers (HMBF) in neonatal care despite additional costs and limited supporting data. No randomized clinical trial has followed infants fed these fortifiers after initial hospitalization. Objective To compare neurodevelopment in infants born weighing <1250 g fed mother's milk with supplemental donor milk and either a HMBF or BMBF. Methods This is a follow-up of a completed pragmatic, triple-blind, parallel randomized clinical trial conducted in Southern Ontario between August 2014 and March 2016 (NCT02137473) with feeding tolerance as the primary outcome. Infants weighing <1250 g at birth were block randomized by an online third-party service to receive either HMBF (n = 64) or BMBF (n = 63) added to mother's milk with supplemental donor milk during hospitalization. Neurodevelopment was assessed at 18-months corrected age using the Bayley Scales of Infant and Toddler Development, Third Edition. Follow-up was completed October 2017. Results Of the 127 infants randomized, 109 returned for neurodevelopmental assessment. No statistically significant differences between fortifiers were identified for cognitive composite scores (adjusted scores 94.7 in the HMBF group and 95.9 in the BMBF group; fully adjusted mean difference, −1.1 [95% CI: −6.5 to 4.4]), language composite scores (adjusted scores 92.4 in the HMBF group and 93.1 in the BMBF; fully adjusted mean difference, −1.2 [−7.5 to 5.1]), or motor composite scores (adjusted scores 95.6 in the HMBF group and 97.7 in the BMBF; fully adjusted mean difference, −1.1 [−6.3 to 4.2]). There was no difference in the proportion of participants that died or had neurodevelopmental impairment or disability between groups. Conclusions Providing HMBF compared to BMBF does not improve neurodevelopment scores at 18-months corrected age in infants born <1250 g otherwise fed a human milk diet. Trial Registration: NCT02137473, clinicaltrials.gov.

scholarly journals Nutritional management of preterm newborn after hospital discharge: energy and nutrients

2017 ◽  
Author(s):  
Elisabetta Villa ◽  
Roberta Barachetti ◽  
Mario Barbarini
Keyword(s):  
Human Milk ◽  
Preterm Infants ◽  
Neonatal Intensive Care ◽  
Convincing Evidence ◽  
The Body ◽  
Post Discharge ◽  
Poor Growth ◽  
Preterm Babies

Preterm infants are at risk for poor growth while in the Neonatal Intensive Care Unit (NICU) and after discharge from the NICU. The main objective is to reach the body composition and rate of growth of a normal fetus/infant of the same post-menstrual age during the first entire year of life. In case of human milk, the limited data do not provide convincing evidence that feeding preterm infants after discharge with multi-nutrient fortified human milk, compared with unfortified, affects important outcomes including growth rates during infancy. Conversely, if formula-fed, post discharge formulas produce short term advantages in growth rate but no long term advantages are demonstrated. It is very important to establish a feeding plan and a follow up for all preterm babies who are discharged from NICU in order to recognize as soon as possible any growth deficit.

scholarly journals Effects on gastroesophageal reflux of donkey milk-derived human milk fortifier versus standard fortifier in preterm newborns. Additional data from Fortilat study.

2020 ◽  
Author(s):  
Francesco Cresi ◽  
Elena Maggiora ◽  
Alice Pirra ◽  
Paola Tonetto ◽  
Carlotta Rubino ◽  
...  
Keyword(s):  
Gastric Emptying ◽  
Gastroesophageal Reflux ◽  
Human Milk ◽  
Preterm Infants ◽  
Ph Monitoring ◽  
Bovine Milk ◽  
Clinical Signs ◽  
Donkey Milk ◽  
Symptom Association Probability ◽  
Human Milk Fortifier

Abstract Background : Feeding intolerance, defined as the inability to digest enteral feeding, is a frequent diagnosis in very preterm infants. It is characterized by abdominal distension, delayed gastric emptying and increased frequency and severity of gastroesophageal reflux (GER). As seen in the FortiLat trial, human milk fortification with the new donkey milk-derived human milk fortifier (DF) seems to improve feeding tolerance in these infants. The aim of this ancillary study of the FortiLat trial was to evaluate the effects of using the DF compared with bovine milk-derived fortifier (BF) on GER in VLBW infants.Methods : Over a total of 156 preterm infants enrolled into the FortiLat trial (gestational age <32 weeks and/or birth weight <1500 g) and randomized into BF-arm or DF-arm we selected all infants with clinical signs of GER and cardiorespiratory (CR) symptoms at day 21 of fortification. All the infants underwent CR and multichannel intraluminal impedance and pH (MII/pH) monitoring associated with gastric ultrasound to evaluate GER characteristics, GER-CR temporal associations and gastric emptying time.Results : 10 infants were enrolled, 5 in the DF-arm. At MII/pH infants enrolled into the DF-arm showed a lower GER frequency than BF-arm infants: 2.02(1.95-3.26) vs 4.82(2.84-5.94) GER/hour (p=0.036). No infant had a significant symptom association probability index between GER and CR events. Half gastric emptying time was similar in DF and BF-arm infants: 45.03(42.74-47.02) vs. 48.57(44.73-48.77) min. (p=0.744)Conclusions : The use of donkey derived human milk fortifier reduced the GER frequency and consequently should be recommended in infants with feeding intolerance.Trial Registration : ISRCTN -ISRCTN70022881. Registered 01May 2014 - Retrospectively registered, http://www.isrctn.com/ISRCTN70022881

scholarly journals Effects of an exclusive human-milk diet in preterm neonates on early vascular aging risk factors (NEOVASC): study protocol for a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Wolfgang Mitterer ◽  
Christoph Binder ◽  
Anya Blassnig-Ezeh ◽  
Lorenz Auer-Hackenberg ◽  
Angelika Berger ◽  
...  
Keyword(s):  
Risk Factors ◽  
Clinical Trial ◽  
Cardiovascular Risk ◽  
Human Milk ◽  
Preterm Infants ◽  
Bovine Milk ◽  
Control Group ◽  
Milk Diet ◽  
Randomized Controlled ◽  
Parallel Group

Abstract Background Preterm birth accounts for approximately 11% of all livebirths globally. Due to improvements in perinatal care, more than 95% of these infants now survive into adulthood. Research has indicated a robust association between prematurity and increased cardiovascular risk factors and cardiovascular mortality. While the innate adverse effects of prematurity on these outcomes have been demonstrated, therapeutic strategies on the mitigation of these concerning developments are lacking. The primary objective of the NEOVASC clinical trial is therefore to investigate whether the administration of a prolonged exclusive human-milk diet in preterm infants is capable of alleviating the harmful effects of preterm birth on the early development of cardiovascular risk factors. Methods The NEOVASC study is a multicentric, prospective, randomized, controlled, open, and parallel group clinical trial conducted in four Austrian tertiary neonatal care facilities. The purpose of the present trial is to investigate the effects of a prolonged exclusive human-milk-diet devoid of bovine-milk-based food components on cardiovascular and metabolic risk factors at 1, 2, and 5 years of corrected age. Primary outcomes include assessments of fasting blood glucose levels, blood pressure levels, and the distensibility of the descending aorta using validated echocardiographic protocols at 5 years of corrected age. The test group, which consists of 200 preterm infants, will therefore be compared to a control group of 100 term-born infants and a historical control group recruited previously. Discussion Given the emerging implications of an increased cardiovascular risk profile in the potentially growing population of preterm infants, further research on the mitigation of long-term morbidities in formerly preterm infants is urgently warranted. Further optimizing preterm infants’ nutrition by removing bovine-milk-based food components may therefore be an interesting approach worth pursuing. Trial registration ClinicalTrials.govNCT04413994. Registered on 4 June 2020.

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