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Effect of maternal colostrum administration on oral mucosa of preterm infants on rates of late neonatal infection

Impact of colostrum administration on the oral mucosa of preterm and very low weight on the sepsis rate: Randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5h2yvf
Enrollment
Unknown
Registered
2018-09-27
Start date
2017-05-05
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Some conditions originating in the perinatal period

Interventions

Intervention Group: 27 preterm infants (gestational age less than 30 weeks gestation) and weighing less than 1500g, will receive (0.1ml of maternal colostrum on the side of the infant's mouth, on the
Other
A12.200.194
HP7.029.152.238.191.207
M01.060.703.520.520
C01.539.757.580

Sponsors

Universidade de Caxias do Sul
Lead Sponsor
Hospital Geral de Caxias do Sul
Collaborator

Eligibility

Age
24 Weeks to 30 Weeks

Inclusion criteria

Inclusion criteria: Newborns with gestational age equal to or less than 30 weeks and / or weighing 1,500 g or less; signing of the Informed Consent Form (TCLE) by the parents or guardians of the concept.

Exclusion criteria

Exclusion criteria: Newborns without child support during hospitalization; RN carriers of complex congenital malformations; neonatal problems that contraindicate colostrum; HIV positive mothers; mothers who use drugs and / or substance abuse that contraindicate the supply of breast milk; use of vasopressor drugs; RN from twin pregnant women.

Design outcomes

Primary

MeasureTime frame
Incidence of late sepsis For the purposes of the research, the diagnosis will be instituted when sepsis occurs after 72 hours of life. The participant should present clinical signs of infection including the following categories and at least one sign in each of the three categories: a) General: fever (temperature above 37.7 ° C), apnea (respiratory pause less than 15 seconds), tachypnea (respiratory rate above 60 movements per minute), respiratory discomfort (use of accessory musculature to breathe); b) Laboratory: leukopenia (decrease of leukocytes lower than 7000), leukocytosis (above 12000), increase of C-reactive protein (over 5); and c) Hemodynamics: hypotension (decrease in mean arterial pressure) tachycardia (heart rate above 160 per minute), altered skin perfusion (capillary filling time over 3 seconds).—

Secondary

MeasureTime frame
Secondary outcomes not expected—

Countries

Brazil

Contacts

Public Contactdaiane vergani

Universidade de Caxias do Sul

dopverga@ucs.br+55-054-991196307

Outcome results

None listed

Source: REBEC (via WHO ICTRP)