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LACTOFERRIN PREVENTION OF NEONATAL SEPSIS

LACTOFERRIN PREVENTION OF NEONATAL SEPSIS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REPEC
Registry ID
PER-113-11
Enrollment
414
Registered
2011-12-27
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-04

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

Conditions

None listed

Interventions

NEWBORNS WILL RECEIVE ORAL BOVINE LACTOFERRIN (200mg/kg/day DIVIDED INTO THREE DAILY DOSE) OR PLACEBO (MALTODEXTRIN 200mg/kg/day DIVIDED INTO THREE DAILY DOSE) FOR 8 WEEKS. BOTH BOVINE AS WELL AS HUMA
THE IDENTITY OF THE SEQUENCE IS 69% (PIERCE ET AL, 1991). 3-D STRUCTURES OF BOVINE AND HUMAN LACTOFERRIN ARE VERY SIMILAR. LACTOFERRIN CONCENTRATION IN HUMAN MILK IS ESTIMATED TO BE 5.3 ± 1.9 MG / ML
HAMOSH, 2001). IN CONTRAST, LACTOFERRIN CONCENTRATION IN BOVINE MILK IS LOW (1.5 mg/mL IN SERUM OF COLOSTRUM AND 20-200 µg/mL IN MILK) (STEIJNS & VAN HOOIJDONK, 2000). ALTHOUGH THERE ARE DIFFERENCES I
TOMITA, 2002). AS PRODUCED MILK VOLUME INCREASES, DECREASES LACTOFERRIN CONCENTRATION. EXIST VARIABILITY IN EVERY MOTHER, HOWEVER THE TOTAL AMOUNT OF NATURAL HUMAN LACTOFERRIN IN MILK CONSUMED BY A

Sponsors

UNIVERSIDAD PERUANA CAYETANO HEREDIA,
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: 1.NEONATES WITH BIRTH WEIGHT BETWEEN 500G and 2000G AT BIRTH TIME. 2. NEONATES BORN IN OR REFERRED TO, THE INTENSIVE OR INTERMEDIATE CARE UNIT OF NEONATOLOGY OF PARTICIPATING HOSPITALS BEFORE MENTIONED, IN THE FIRST 72 HOURS OF LIFE.

Exclusion criteria

Exclusion criteria: 1. NEONATES WITH UNDERLYING GASTROINTESTINAL PROBLEMS THAT MAKES IMPOSSIBLE ORAL ROUTE. 2. NEONATES WITH UNDERLYING CONDITIONS DEEPLY AFFECTING GROWTH AND DEVELOPMENT (CHROMOSOMAL ABNORMALITIES, STRUCTURAL BRAIN ABNORMALITIES, SEVERE CONGENITAL ABNORMALITIES). 3. NEONATES WITH A FAMILIAR HISTORY OF ALLERGY TO COW´S MILK. 4. ANY NEONATE THAT IN AGREEMENT WITH THE RESEARCHER´S CRITERIA DON´T HAVE THE POSSIBILITY TO COMPLETE THE STUDY MONITORING VISITS (PATIENT THAT BEFORE TWO MONTHS OF AGE MUST RETURN TO PROVINCE). 5. NEONATES WHOSE PARENTS DO NOT WANT TO PARTICIPATE.

Countries

Peru

Contacts

Public ContactJaime Zegarra

UNIVERSIDAD PERUANA CAYETANO HEREDIA

jaime.zegarra@upch.pe999708745

Outcome results

None listed

Source: REPEC (via WHO ICTRP)