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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Holder pasteurization | Active Comparator | Donor milk pasteurized by Holder method (62.5ºC, 30 minutes) |
|
| HTST pasteurization | Experimental | Donor milk pasteurized by High Temperature Short Time (HTST) method (72ºC, 15 seconds) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| donor milk | Other | pasteurized donor milk |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiological proven late onset sepsis rate | Incidence of Microbiological proven late onset sepsis expressed as a percentage | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Central line associated bloodstream infections (CLABSI) rate | Number of CLABSI events per 1000 catheter-days | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks |
| Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate |
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Inclusion Criteria (all criteria are necessary) :
Exclusion Criteria:
Post-randomization exclusion criteria:
- Randomized infant who do not fulfill inclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Carmen Rosa Pallas Alonso | Hospital Universitario 12 de Octubre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital 12 de Octubre | Madrid | 28041 | Spain | |||
| Hospital Universitario La Paz |
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| ID | Term |
|---|---|
| D000071074 | Neonatal Sepsis |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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Parallel assignment
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Incidence of NEC nad late onset sepsis as a percentage |
| From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks |
| Mortality rate | Percentage of preterm infant died during the study | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks |
| Oxygen supplementation | Percentage of infants with respiratory assistance with fraction of inspired oxygen greater than 0.21 at 36 weeks postmenstrual age | Assessed up to 24 weeks |
| Stage 3-5 Retinopathy | Percentage of infants diagnosed with retinopathy by the ophthalmologist | From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks |
| Growth velocity | Growth calculated as the weight gain in g/kg/day | Assessed up to 24 weeks |
| Madrid |
| 28046 |
| Spain |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |