Preterm newborn
Conditions
Interventions
Randomized, controlled, double-blind clinical trial to be performed at HCCriança-HCFMRP-USP. They will be allocated to two groups: one group will receive milk with a heterologous additive (FM85) used
Dietary supplement
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Eligibility
Age
0 Days to 14 Days
Inclusion criteria
Inclusion criteria: It will be included in this study, very low birth weight newborns (VLBWN) who were admitted to the Intensive Care Units and Neonatal Intermediate Care of the Children’s Hospital of Ribeirão Preto Medical School - University of São Paulo (HC-FMRP-USP). Parent or legal guardian needs to sign the informed consent to participate in the research. Inclusion criteria for LBWN are: male and female sexes; who had birth weight >= 750 grams and <= 1500 grams in Phase 1 and less than or equal to 1500 grams in Phase 2; from any ethnicity; prematurely born (less than 37 weeks of gestational age); considered small (SGA) or adequate for gestational age (AGA); receiving human milk, whether raw maternal (which will be kept) and / or human milk from the bank in the volume of 100 ml / kg / day; whose mother, father or legal guardian authorizes participation in this study and, thus, signed the Free and Informed Consent Form; in a situation of twinning, one of the newborns will be drawn for each group; stable hemodynamically, without use of vasoactive drugs.
Exclusion criteria
Exclusion criteria: The exclusion criteria (Phase 1 and Phase 2) will be: newborns considered large for gestational age; that presence of major malformations; periventricular and intraventricular hemorrhage (HPIV) degrees III and IV; children of minor mothers without accompanying.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In Phase 1 the occurrence of possible adverse events will be observed as primary outcome: necrotizing enterocolitis or death or sepsis or septic shock or gastrointestinal bleeding. In phase 2, it will be observed as primary outcome: linear growth (length and cranial perimeter) ;Enterocolitis Necrotizing: Criteria for Bell 1 B or more severe verified by clinical method, abdominal Rx, abdomen ultrasound, hemograms, CRP and blood cultures. Eventually exploratory laparotomy. Mean incidence in the Brazilian Network of Neonatal Research of 7%, values higher than this will be considered serious adverse effects. Action: Suspension of diet (minimum of 1 week) + antibiotic therapy; Death: Mortality should be less than 10% for very low birth weight infants (?1500g) Neonatal sepsis: Presentation of the following symptoms (Shane, Sánchez, & Stoll, 2017); General: fever, thermal instability, edema, malnutrition, bad appearance; Gastrointestinal: abdominal distension, vomiting, diarrhea or hepatomegaly; Respiratory system: apnea, dyspnea, tachypnea, intercostal retractions, nasal wings beat, motility and cyanosis; Renal system: oliguria; Cardiovascular system: pallor, mottled, cold or sticky skin, tachycardia, hypotension or bradycardia; Central Nervous System: irritability, lethargy, tremors, seizures, hyporeflexia, hypotonia, abnormal Moro reflex, irregular breathing, bulging fontanelle, abnormal crying; Hematologic system: jaundice, splenomegaly, pallor, petechiae, purpura and bleeding; Laboratory: hemogram with leukocytosis, left shift or leukopenia, with qualitative changes such as toxic granulations and microvacúols. Identification of bacterium or fungus by blood culture, culture of cerebrospinal fluid or urine; Sepsis will be confirmed by culture, and children will be divided into suspected and confirmed sepsis according to this criterion. Action: diet suspension until full hemodynamic stability is restored, if it is associated with necrotizing enterocolitis, for at least | — |
Secondary
| Measure | Time frame |
|---|---|
| In stage 1 the secondary outcomes will be: vomiting or diarrhea or abdominal distension or suspension of the diet, for any period, which should be computed in hours. In phase 2 all the outcomes described in Phase 1 will be observed;Gastrointestinal bleeding: observation of gastrointestinal bleeding by clinical evaluation of the presence of melena, hematemesis or enterorrhagia. Action: medical evaluation of continuity or non-continuity of the diet depending on the amount and cause; Vomiting: defined as the return of a larger amount of food to the fullest emptying of the stomach and usually occurs at some time after feeding (Rigo et al., 2017). Action: medical evaluation of continuity or non-continuity of diet according to expelled content and recurrence; Diarrhea: Increased net stool content or number of bowel movements out of the normal pattern observed in the child. The stool pattern: will be evaluated according to frequency and consistency: 5 = hard; 4 = formed; 3 = mole; 2 = liquid or 1 = watered down Action: medical evaluation of whether or not diet is continued; Abdominal distension: Increased abdominal circumference greater than 10% in relation to the last routine measure not considered distension; Action: medical evaluation of the continuity or non-continuity of the diet depending on the presence of pain and / or appearance of the abdomen (redness, and / or association with vomiting and diarrhea and / or anomalous (bloody or greenish) residues, tested if necessary. | — |
Countries
Brazil
Contacts
Public ContactJosé Camelo Junior
Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Outcome results
None listed