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Colostrum administration in very low birth weight preterm infants - clinical trial

Oral immunotherapy in very low birth weight preterm infants - randomized double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-83dk7z
Enrollment
Unknown
Registered
2017-01-25
Start date
2017-01-01
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

prematurity, very low birthweight, infant nutrition, infection

Interventions

Starting within 96 hours of life, colostrum administration, 0.1ml on each side of the oral mucosa, using 1 ml syringe, 2/2h or 3/3h (coinciding with the diet) for the first 7 days and mother's own mil
Biological/vaccine

Sponsors

Hospital Moinhos de Vento
Lead Sponsor
Faculdade de Medicina da Pontífice Universidade Católica do Rio Grande do Sul
Collaborator

Eligibility

Age
0 Hours to 96 Hours

Inclusion criteria

Inclusion criteria: Premature inborn at Hospital Moinhos de Vento; with birth weight equal to or below 1500 grams; and/or gestational age equal to or less than 30 weeks; admitted to the NICU.

Exclusion criteria

Exclusion criteria: Malformations incompatible with life; malformation of the gastrointestinal tract; contraindication to breast milk; death in the first 6 days of life.

Design outcomes

Primary

MeasureTime frame
Late onset sepsis incidence: number of patients who had the presence of pathogenic bacteria in blood culture and / or cerebrospinal fluid collected after the 3rd day of life. If the bacterial pathogen is a negative coagulase stafilo, sepsis will be considered only if accompanied by one or more signs of generalized infection (apnea, temperature instability, feeding intolerance, worsening of respiratory symptoms or hemodynamic instability) AND if the patient received at least 5 days IV antibiotics after positive cultural.

Secondary

MeasureTime frame
Volume of breast milk at discharge: defined as proportion of mother's milk received on discharge day, either through breast or bottle, in relation to the total volume of diet received.;Mortality: number of patients who died during the trial.;Prevalence of necrotizing enterocolitis (NEC): number of patients who present with surgical or clinical and radiological diagnosis that meets the following criteria - presence of at least ONE of the following clinical signs: gastric residue or bilious aspect of vomiting, abdominal distension, hidden or visible blood in stool and at least ONE of the following radiological findings: pneumatosis intestinalis, gas in the hepatobiliary system, pneumoperitoneum.;Prevalence of bronchopulmonary dysplasia (BPD): number of patients that need to use oxygen at 36 weeks corrected age. ;Prevalence of retinopathy of prematurity (ROP): number of patients that present retinopathy to ophthalmologic examination, grade 1 to grade 5. ;Prevalence of periventricular hemorrhage: number of patients with presence of hemorrhage in cranial ultrasound performed before 28 days, classified as grade I to IV, according to the criteria Papille et al. ;Number of days needed to reach full enteral feeding, considered as the volume of (150 ml / kg / day). ;Length of stay in days ;Prevalence of extra-uterine growth restriction: number of patients who present with weight and / or head circumference below the 10th percentile, according to the growth curve of Fenton 2013, at discharge or at 40 weeks corrected age, whichever occurs first.

Countries

Brazil

Contacts

Public ContactMariana de Oliveira

Hospital Moinhos de Vento

marianagdeoliveira@gmail.com+55-51-3537-8820

Outcome results

None listed

Source: REBEC (via WHO ICTRP)