Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: Study protocol of a randomized controlled clinical trial

Abstract Background Fortification of human milk is a standard practice for feeding very low birth weight infants. However, preterm infants often still experience suboptimal growth and feeding intolerance. New fortification strategies and different commercially available fortifiers have been developed. Commercially available fortifiers are constituted by a blend of ingredients from different sources, including plant oils and bovine milk proteins, thus presenting remarkable differences in the quality of macronutrients with respect to human milk. Based on the consideration that donkey milk has been suggested as a valid alternative for children allergic to cow’s milk proteins, due to its biochemical similarity to human milk, we hypothesized that donkey milk could be a suitable ingredient for developing an innovative human milk fortifier. The aim of the study is to evaluate feeding tolerance, growth and clinical short and long-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk, in comparison to an analogous population fed with traditional fortifier and protein supplement containing bovine milk proteins. Methods The study has been designed as a randomized, controlled, single-blind clinical trial. Infants born <1500 g and <32 weeks of gestational age were randomized to receive for 21 days either a combination of control bovine milk-based multicomponent fortifier and protein supplement, or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The fortification protocol followed is the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. Weight, length and head circumference are measured; feeding tolerance is assessed by a standardized protocol. The occurrence of sepsis, necrotizing enterocolitis and adverse effects are monitored. Discussion This is the first clinical study investigating the use of a human milk fortifier derived from donkey milk for the nutrition of preterm infants. If donkey milk derived products will be shown to improve the feeding tolerance or either of the clinical, metabolic, neurological or auxological outcomes of preterm infants, it would be an absolute innovation in the field of feeding practices for preterm infants. Trial registration ISRCTN - ISRCTN70022881

Urinary Metabolomic Profile of Preterm Infants Receiving Human Milk with Either Bovine or Donkey Milk-Based Fortifiers

Fortification of human milk (HM) for preterm and very low-birth weight (VLBW) infants is a standard practice in most neonatal intensive care units. The optimal fortification strategy and the most suitable protein source for achieving better tolerance and growth rates for fortified infants are still being investigated. In a previous clinical trial, preterm and VLBW infants receiving supplementation of HM with experimental donkey milk-based fortifiers (D-HMF) showed decreased signs of feeding intolerance, including feeding interruptions, bilious gastric residuals and vomiting, with respect to infants receiving bovine milk-based fortifiers (B-HMF). In the present ancillary study, the urinary metabolome of infants fed B-HMF (n = 27) and D-HMF (n = 27) for 21 days was analyzed by1H NMR spectroscopy at the beginning (T0) and at the end (T1) of the observation period. Results showed that most temporal changes in the metabolic responses were common in the two groups, providing indications of postnatal adaptation. The significantly higher excretion of galactose in D-HMF and of carnitine, choline, lysine and leucine in B-HMF at T1 were likely due to different formulations. In conclusion, isocaloric and isoproteic HM fortification may result in different metabolic patterns, as a consequence of the different quality of the nutrients provided by the fortifiers

Promoting the Execution of Judgments of the European Court of Human Rights: The (Potential) Role of National Human Rights Institutions

The acknowledgment that the European Court of Human Rights (ECtHR) and the Committee of Ministers are flooded with repetitive cases has brought increasing attention to the issue of full and timely execution of the Court’s judgments. Efforts have been made to render the system of supervision of the execution more transparent, independent, and participatory. The involvement of actors other than the intergovernmental Committee of Ministers appears particularly significant. This dissertation focuses on specific entities that, while somewhat neglected in the literature, would seem to be ideally situated to promote the execution of ECtHR judgments – i.e., National Human Rights Institutions (NHRIs), which are commonly portrayed as “bridges” between the State and civil society, and between the national and international levels. The dissertation provides a comprehensive examination of the current level of engagement by NHRIs with the Committee of Ministers for furthering the execution of ECtHR judgments. Participating NHRIs have generally provided detailed information on the state of legislation, administrative practice, and case-law in their respective countries, and they have proposed measures to prevent future human rights violations. Nonetheless, the findings show that a relatively low number of NHRIs have submitted communications to the Committee of Ministers to date and that the impact of these communications on the actions undertaken by States and the decisions adopted by the Committee of Ministers is often difficult to assess. The activities carried out by NHRIs at the domestic level to encourage the execution of ECtHR judgments are also systematically identified with a view to illustrating the multifarious ways in which NHRIs can contribute to the execution process. On the basis of these findings, the dissertation highlights and accounts for the unfulfilled potential of NHRIs in promoting the execution of ECtHR judgments; it further puts forward proposals to strengthen the involvement of NHRIs in the process