A novel human milk fortifier derived from donkey milk for the nutrition of preterm or low-weight newborns

Randomized controlled clinical trial in single-blind to evaluate the nutritional adequacy of a novel human milk fortifier derived from donkey milk for the nutrition of preterm or low-weight newborns

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN70022881

Enrollment

124

Registered

2017-05-10

Start date

2014-11-27

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enteral nutrition in very low birthweight infants Neonatal Diseases

Interventions

Starting from the first fortifier administration, i.e., after reaching an enteral feeding = 80ml/kg/d, newborns included in the trial will be randomized 1:1 by a software-generated list to the followi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Gestational age 80% of the total 3. Enteral feeding =80ml/kg/d of human milk reached within the first 4 weeks of life 4. Informed consent by a parent

Exclusion criteria

Exclusion criteria: 1. Severe gastrointestinal pathologies (diagnosed or suspect necrotizing enterocolitis, colostomy, intestinal obstruction, symptoms of peritonitis, presence of blood in the feces) 2. Chromosomal abnormalities or major malformations 3. Hereditary metabolic pathologies 4. Intravascular disseminated coagulation (IDC), shock 5. Patent Ductus Arteriosus (PDA) requiring medical care or surgery 6. Severe renal insufficiency (serum creatinine > 2 mg/dl)

Design outcomes

Primary

Measure	Time frame
Occurrence of at least one episode of alimentary intolerance, defined as the necessity to interrupt enteral feeding for more than 8 consecutive hours during the study period from T0 to T3 (day 21)	—

Secondary

Measure	Time frame
1. Short-term outcome measures: 1.1. Number of alimentary intolerance episodes, measured using clinical protocol focused on feeding tolerance every day during observational period (T0-T3) 1.2. Number of feeding interruption episodes (even for periods shorter than 8 hours) , measured using clinical protocol focused on feeding tolerance every day during observational period (T0-T3) 1.3. Total hours of enteral feeding interruption, measured using clinical protocol focused on feeding tolerance every day during observational period (T0-T3) 1.4. Time required to reach full enteral feeding (150 ml/kg/d of enteral feeding), measured using evaluation of clinical records at discharge 1.5. Variation of anthropometric indices (weight, length and cranial circumference), measured using weight, length, cranial circumference scale during the study period and at 40 ± 1 weeks of postmenstrual age 1.6. Hospitalization duration, measured using evaluation of clinical records at discharge 2. Clinical indices, measured using clinical evaluation at discharge: 2.1. Necrotizing enterocolitis (NEC), classified following Bell stages 2.2. Suspected or diagnosed sepsis 2.3. Death 3. Analytical parameters, measured using specific tests conducted in laboratory analysis: 3.1. Calcium, phosphorus, alkaline phosphatase, BUN, creatinine and albumin, measured at T0, T1, T2 and T3 3.2. Amino acid profile in plasma and urine, measured at T0 and T3 3.3. Indices of metabolic acidosis (pH, BE, bicarbonates), measured at T0, T1, T2 and T3 4. Gastic emptying time, assessed using echography at T3 in patients with GERD symptoms 5. Gastroesophageal reflux, assessed using pH-impedance monitoring at T3 in patients with GERD symptoms 6. Urinary metabolomic profile, measured using NMR metabolomics at T0 and T3 7. Faecal analysis (calprotectin), measured using specific tests conducted in laboratory analysis at T0 and T3 8. Occurrence of other pathological events, measured using clinical evaluation during the study	—

Measure

Time frame

1. Short-term outcome measures: 1.1. Number of alimentary intolerance episodes, measured using clinical protocol focused on feeding tolerance every day during observational period (T0-T3) 1.2. Number of feeding interruption episodes (even for periods shorter than 8 hours) , measured using clinical protocol focused on feeding tolerance every day during observational period (T0-T3) 1.3. Total hours of enteral feeding interruption, measured using clinical protocol focused on feeding tolerance every day during observational period (T0-T3) 1.4. Time required to reach full enteral feeding (150 ml/kg/d of enteral feeding), measured using evaluation of clinical records at discharge 1.5. Variation of anthropometric indices (weight, length and cranial circumference), measured using weight, length, cranial circumference scale during the study period and at 40 ± 1 weeks of postmenstrual age 1.6. Hospitalization duration, measured using evaluation of clinical records at discharge 2. Clinical indices, measured using clinical evaluation at discharge: 2.1. Necrotizing enterocolitis (NEC), classified following Bell stages 2.2. Suspected or diagnosed sepsis 2.3. Death 3. Analytical parameters, measured using specific tests conducted in laboratory analysis: 3.1. Calcium, phosphorus, alkaline phosphatase, BUN, creatinine and albumin, measured at T0, T1, T2 and T3 3.2. Amino acid profile in plasma and urine, measured at T0 and T3 3.3. Indices of metabolic acidosis (pH, BE, bicarbonates), measured at T0, T1, T2 and T3 4. Gastic emptying time, assessed using echography at T3 in patients with GERD symptoms 5. Gastroesophageal reflux, assessed using pH-impedance monitoring at T3 in patients with GERD symptoms 6. Urinary metabolomic profile, measured using NMR metabolomics at T0 and T3 7. Faecal analysis (calprotectin), measured using specific tests conducted in laboratory analysis at T0 and T3 8. Occurrence of other pathological events, measured using clinical evaluation during the study

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Countries

Italy

Contacts

Public ContactEnrico Bertino

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 7, 2026