Not provided
Not provided
Not provided
Not provided
The study was stopped when 85% of the sample wascompleted due to the time elapsed and the estimated lack of change in results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study evaluates the utility of measuring gastric residuals in premature infants born between 26+0 and 33+6 weeks and to determine if its routine use is related with a delay in feedings advancement in this babies compared with no measurement.
The evaluation of gastric residuals as a measure of enteral tolerance in term and especially preterm newborns is a widely used practice in different centers worldwide. However, until now, it continues to be a controversial practice, since its real usefulness is not clear.
Our study proposes to evaluate and compare two groups of preterm newborns born between 26 + 0/7 and 33 + 6/7 weeks, randomized to measure or not measure gastric residuals and determine if this practice delays the full feeding achievement.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine aspiration of gastric residuals | Active Comparator | Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. |
|
| No aspiration of gastric residuals | No Intervention | Infants will not have routine aspiration of gastric contents prior to each feeding. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspiration of gastric residuals | Procedure | Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to reach full feeds | Time in days to reach full feeds defined as receiving 150 ml/kg/day tolerated for at least 24 hrs. | Baseline to 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Valentina A Salas, MD | Pontificia Universidad Catolica de Chile | Principal Investigator |
| Jorge G Fabres, MD, MSPH | Pontificia Universidad Catolica de Chile | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pontificia Universidad Católica de Chile | Santiago | Santiago Metropolitan | 8330077 | Chile |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007235 | Infant, Premature, Diseases |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided