Very Low Birth Weight Infant Clinical Trial
Official title:
Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study
Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations or an insufficient GIT anastomosis after surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a strong osmotic effect and leads to water influx into the intestine lumen. Thereby the peristaltic movement is accelerated and the premature infant excretes stool during the hours following application. Therefore Gastrografin might be effective to mobilize meconium from small bowel and deep parts of the colon. The investigators hypothesized that enteral application of Gastrografin accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.
In premature infants the establishment of proper gastrointestinal function is challenging
and often associated with delayed meconium passage. Meconium evacuation depends on
gestational age and birthweight: the more immature an infant is, the later meconium passage
starts and the longer meconium passage lasts. The mean duration of meconium evacuation in
premature infants with a gestational age below 30 weeks is 8 days, while mature infants
excrete their meconium in 2 days. The obstruction of deep intestinal segments by tenacious,
sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food
passage. The time lag to full enteral feedings is extended, the probability to acquire
infections due to intravenous access for parenteral nutrition increases and the hospital
stay of the infant is prolonged. However, the relation between meconium passage and feeding
tolerance remains controversial. While one study showed that there is little concordance
between first meconium passage and feeding tolerance, an other one showed that rapid and
complete excretion of meconium is crucial for oral feeding tolerance and has a positive
effect on it. Recently, the investigators performed a prospective randomized trial to
determine, whether repeated prophylactic applications of small volume glycerin enemas
accelerate passage of meconium in very low birth weight (VLBW) infants. Disappointingly,
application of enemas did not accelerate meconium evacuation. A possible reason for the
ineffectiveness of glycerin enemas is that the volume used was too small to mobilize
tenacious meconium sufficiently from the colon and small bowel.
Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can
be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect
otherwise radiologically invisible perforations or an insufficient GIT anastomosis after
surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a
strong osmotic effect and leads to water influx into the intestine lumen. Thereby the
peristaltic movement is accelerated and the premature infant excretes stool during the hours
following application. Therefore Gastrografin might be more effective to mobilize meconium
from small bowel and deep parts of the colon. The investigators hypothesized, that enteral
application of Gastrografin accelerates meconium evacuation in premature infants, and
thereby enhances feeding tolerance in this population. The objective of the present study is
to determine whether the enteral application of the osmotic contrast agent Gastrografin®
accelerates complete meconium excretion and improves feeding tolerance in very low birth
weight infants.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Not yet recruiting |
NCT04041765 -
IgM-Enriched Immunoglobulin for Neonatal Sepsis
|
Phase 3 | |
Completed |
NCT01683760 -
Pharmacokinetic Study of Fluconazole in Premature Infants
|
Phase 2 | |
Completed |
NCT04282655 -
Effect of Milk Warming on the Very Low Birth Weight Infant
|
N/A | |
Active, not recruiting |
NCT05436925 -
CGM Use in Preterm Infants
|
||
Recruiting |
NCT04497012 -
Iron Supplementation and Intestinal Health
|
Phase 4 | |
Recruiting |
NCT05308134 -
Individualized Fortification of Human Milk for Infants Born ≤ 1250 g (MaxiMoM-InForM)
|
N/A | |
Completed |
NCT03682575 -
Work of Breathing in Premature Infants at Discharge
|
||
Terminated |
NCT02987764 -
Cord Milking Impacts Neurodevelopmental Outcomes in Very Low Birth Weight Infants
|
N/A | |
Completed |
NCT05686252 -
RCT: The Effect of Held Position During Kangaroo Care on Physiological Parameters of Premature Infants
|
N/A | |
Not yet recruiting |
NCT05806684 -
Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
|
||
Completed |
NCT03916159 -
Extrauterine Placental Transfusion In Neonatal Resuscitation Of Very Low Birth Weight Infants
|
N/A | |
Not yet recruiting |
NCT04640805 -
Targeted Fortification of Pasteurized Donor Human Milk
|
N/A | |
Completed |
NCT06200324 -
Clinical Outcomes of Ready-to-Use Parenteral Nutrition in Low Birth Weight Newborns in Colombia 2017-2023
|
||
Completed |
NCT05022433 -
Comparison of the Shukla and UN-1 Formulae in the Placement of the Umbilical Venous Catheter Among Neonates
|
||
Not yet recruiting |
NCT03163212 -
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
|
Early Phase 1 | |
Completed |
NCT00962754 -
Fluid Balance Study in Sick Neonates
|
Phase 4 | |
Not yet recruiting |
NCT06433674 -
Enteral Zinc Supplementation in Very Low Birth Weight Infants
|
Phase 3 | |
Recruiting |
NCT05961657 -
USCOM Parameters in Preterm Infants: Reference Ranges
|
||
Completed |
NCT05406804 -
Olfactory Stimulation for Very Low Birth Weight Infants
|
N/A |