Infant, Premature
Conditions
Interventions
For the intervention group, formed for 175 newborns, the mother's own colostrum will be used and the treatment regimen will be made daily by 8 administrations of 0.2 ml (four drops) of colostrum for 1
and then the same syringe containing 0.1 ml (two drops) of remaining colostrum will be administered into the left oral mucosal tissue by the twelfth. During the procedure the heart rate, temperature,
and it will be immediately discontinued if observed: signs of agitation, episode of desaturation with oxygen saturation less than 88% or perception of change of vital signs
and, the newborn will be accompanied by a clinical, nutritional and weight-stature clinical form.
Treatment of more than 75% of planned doses will be considered complete treatment.
The historical cont
Biological/vaccine
Sponsors
Universidade Estadual de Feira de Santana
Hospital Inácia Pinto dos Santos
Eligibility
Age
0 Hours to 72 Hours
Inclusion criteria
Inclusion criteria: Infants admitted to Neonatal Units; birth weight less than or equal to 1500g; less than or equal to 37 gestational weeks; zero diet by oral and enteral route or in total parenteral nutrition; clinically stable; until 24 hours of life.
Exclusion criteria
Exclusion criteria: Referring to the mother: maternal history of substance or drug abuse; presence of psychological disorder; multiple gestation from triplets; contraindications for breastfeeding (retroviruses and cytomegalovirus). Regarding the newborn: use of vasopressor medication greater than 10mcg / kg / min; needing for immediate surgical intervention; presence of syndromes and / or congenital malformations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Attributable Risk of death, measured by the difference of the mortality coefficients beteen exposed and non-exposed group. The parameter is the medical record, based on the permanent disappearance of any sign of life, at any time after birth until discharge. | — |
Secondary
| Measure | Time frame |
|---|---|
| Period of antibiotic use in the Neonatal Unit, measured by the average difference of at least 1 day between the exposed and non-exposed groups, evaluated by medical prescription in medical records.;Bronchopulmonary dysplasia, measured by the difference in its incidence between the exposed and non-exposed groups, evaluated by recording the diagnosis of the doctor of the service, having as a parameter: presence of mechanical ventilation, signs of chronic respiratory disease, X-ray with changes and oxygen supplementation for more than 28 days to achieve PaO2 greater than 50 mmHg.; Hyaline membrane disease, measured by the difference in its incidence between the exposed and non-exposed groups, evaluated by recording the diagnosis of the doctor of the service, taking as a parameter the presence of respiratory dysfunction in the first minutes of life, accompanied by tachypnea , groaning, sternal retractions; and X-ray with pulmonary hypo-insufflation and reticulo-granular infiltrate.;Necrotizing enterocolitis, measured by the difference in its incidence between exposed and non-exposed groups, evaluated by the medical diagnosis of the service, using the criteria of Bell et al (1978) as of Stage II: Systemic Symptoms - Stage Signs I, mild metabolic acidosis, thrombocytopenia, altered peripheral perfusion; Gastrointestinal signs - signs of Stage I, absence of airflow sounds, palpation sensitivity, mass in the QID; Radiologic findings - intestinal dilation, intestinal pneumatosis, air in the portal system.;Intraventricular hemorrhage, measured by the difference in its incidence between the exposed and non-exposed groups, evaluated by the medical diagnosis of the service, characterized as an acute condition with deep coma, hypoventilation, apnea, seizure and arrest pupils, associated with transfontanel ultrasonography and classified according to Papile et al. (1978).;Acute renal failure, as measured by the difference in its incidence between the exposed and non-exposed groups | — |
Countries
Brazil
Contacts
Public ContactGraciete Vieira
Universidade Estadual de Feira de Santana
Outcome results
None listed