Late-Onset Neonatal Sepsis
Conditions
Keywords
neonatal sepsis, extremely low birth weight infant, donor milk, HTST pasteurization, Holder pasteurization
Brief summary
Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (\<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.
Detailed description
Donor milk pasteurized by an innovative High Temperature Short Time (HTST) system (patented by researchers) retains more immune and trophic compounds than pasteurized milk by traditional Holder method. These compounds are related to the protection conferred by breast milk against nosocomial sepsis and necrotizing enterocolitis in preterm infants, so it would be of interest to study if there is a clinical benefit in these patients when health professionals are supplementing with donor milk pasteurized by both methods. The purpose of this study is to compare the incidence of microbiological proven late onset sepsis in newborns under 1000 grams that in the first 28 days of life need to be supplemented with donor milk pasteurized by HTST method versus the Holder method. This is a randomized double-blind clinical trial with parallel assignment. A total of 305 premature babies with a birth weight of less than 1000 grams will be recruited, admitted to the Neonatology Services of the Hospital 12 de Octubre and the Hospital de La Paz and meet the inclusion criteria. Half of the patients will be supplemented exclusively with donor milk pasteurized by the HTST system and the other half with pasteurized milk by the Holder method. Linear generalized models will be used for longitudinal data analysis.
Interventions
OTHERdonor milk
pasteurized donor milk
Sponsors
Carmen Rosa Pallas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
Inclusion criteria
(all criteria are necessary) : * Infants weighing 1000 grams or less at birth * Infants born or transferred before the third day of life to the participating centers * Start enteral feeding in the first week of life * Receive any amount of donor milk in the first 28 days of life * Informed consent signed by parents or legal guardians
Exclusion criteria
* Language barrier * Infants with chromosomopathies * Infants with major congenital malformations * Infants with severe asphyxiation (cord pH or first arterial pH \<7) * Infants included in another clinical trial that modifies nutritional management * Infants who previously fed with formula Post-randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbiological proven late onset sepsis rate | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks | Incidence of Microbiological proven late onset sepsis expressed as a percentage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks | Incidence of NEC nad late onset sepsis as a percentage |
| Mortality rate | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks | Percentage of preterm infant died during the study |
| Central line associated bloodstream infections (CLABSI) rate | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks | Number of CLABSI events per 1000 catheter-days |
| Stage 3-5 Retinopathy | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks | Percentage of infants diagnosed with retinopathy by the ophthalmologist |
| Growth velocity | Assessed up to 24 weeks | Growth calculated as the weight gain in g/kg/day |
| Oxygen supplementation | Assessed up to 24 weeks | Percentage of infants with respiratory assistance with fraction of inspired oxygen greater than 0.21 at 36 weeks postmenstrual age |
Countries
Spain
Outcome results
None listed