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 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 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 Factors associated with neurodevelopment in preterm infants with systematic inflammation

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Eun Sun Lee ◽  
Ee-Kyung Kim ◽  
Seung han Shin ◽  
Young-Hun Choi ◽  
Young Hwa Jung ◽  
...  
Keyword(s):  
White Matter ◽  
Preterm Infants ◽  
Systemic Inflammation ◽  
Head Circumference ◽  
Brain Mri ◽  
White Matter Injury ◽  
Social Emotional ◽  
Postmenstrual Age ◽  
Neurodevelopmental Impairment ◽  
Near Term

Abstract Background Several studies have suggested that adverse neurodevelopment could be induced by systemic inflammation in preterm infants. We aimed to investigate whether preterm infants with systemic inflammation would have impaired neurodevelopment and which biomarkers and neurophysiologic studies during inflammation are associated with poor neurodevelopment. Methods This prospective cohort study enrolled infants born before 30 weeks of gestation or with birth weight < 1250 g. Infants were grouped according to the presence of systemic inflammation: Control (no inflammation, n = 49), I (systemic inflammation, n = 45). Blood and cerebrospinal fluid samples for markers of brain injury and inflammation were collected and amplitude-integrated electroencephalography (aEEG) was performed within 4 h of septic workup. We evaluated aEEG at 35 weeks postmenstrual age (PMA), head circumference at 36 weeks PMA, and brain MRI at discharge. The Bayley Scales of Infant and Toddler Development III (Bayley-III) was performed at a corrected age (CA) of 18 months. Results The I group had more white matter injuries (2 vs. 26.7%, Control vs. I, respectively) at the time of discharge, lower brain functional maturation (9.5 vs. 8), and smaller head size (z-score − 1.45 vs. -2.12) at near-term age and poorer neurodevelopment at a CA of 18 months than the control (p < 0.05). Among the I group, the proportion of immature neutrophils (I/T ratios) and IL-1 beta levels in the CSF were associated with aEEG measures at the day of symptom onset (D0). Seizure spike on aEEG at D0 was significantly correlated with motor and social-emotional domains of Bayley-III (p < 0.05). The I/T ratio and CRP and TNF-α levels of blood at D0, white matter injury on MRI at discharge, head circumference and seizure spikes on aEEG at near-term age were associated with Bayley-III scores at a CA of 18 months. Conclusions Systemic inflammation induced by clinical infection and NEC are associated with neurodevelopmental impairment in preterm infants. The seizure spike on aEEG, elevated I/T ratio, CRP, and plasma TNF-alpha during inflammatory episodes are associated with poor neurodevelopment.

scholarly journals Human milk feeding and cognitive outcome in preterm infants: the role of infection and NEC reduction

2021 ◽  
Author(s):  
Winok Lapidaire ◽  
Alan Lucas ◽  
Jonathan D. Clayden ◽  
Chris Clark ◽  
Mary S. Fewtrell
Keyword(s):  
Breast Milk ◽  
Human Milk ◽  
Preterm Infants ◽  
Neonatal Infection ◽  
Necrotising Enterocolitis ◽  
Cognitive Outcome ◽  
Standard Diet ◽  
Risk Of Infection ◽  
Verbal Iq

Abstract Background Breast milk has been associated with lower risk of infection and necrotising enterocolitis (NEC) and improved long-term cognitive outcomes in preterm infants but, if unsupplemented, does not meet the nutritional requirements of preterm infants. Methods Preterm infants were randomised to receive a high nutrient intervention diet: preterm formula (PTF) or the standard diet: term formula (TF) or banked donor breast milk (BBM), either as their sole diet or as supplement to maternal breast milk (MBM). IQ tests were performed at ages 7, 15, 20, and 30 years. Results An increase in MBM and BBM intake was associated with a lower chance of neonatal infection/NEC. Neonatal infection/NEC was associated with lower Full Scale IQ (FSIQ) and Performance IQ (PIQ) score at ages 7 and 30 years. The relationship between higher intake of MBM and PIQ at age 7 years was partly mediated by neonatal infection/NEC. The intervention diet was associated with higher Verbal IQ (VIQ) scores compared to the standard diet. There was no evidence that these effects changed from childhood through to adulthood. Conclusions Neonatal diet is an important modifiable factor that can affect long-term cognitive outcome through a ‘human milk’ factor, protecting against infection/NEC, and a ‘nutrient content’ factor. Impact This is the first study to demonstrate the effects of neonatal infection/necrotising enterocolitis (NEC) on IQ in the same cohort in childhood and adulthood. Diet can be a key factor in long-term cognitive outcome in people born preterm by preventing neonatal infection/NEC and providing adequate nutrients. Human milk, whether MBM or BBM, is associated with a reduced risk of infection/NEC. A higher nutrient diet is associated with better cognitive outcome in childhood. Performance IQ is particularly vulnerable to the effects of infection/NEC and verbal IQ to the quantity of (macro)nutrients in the diet.

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