Prematurity Clinical Trial
— GRASSOfficial title:
A Prospective, Randomized and Controlled Trial Comparing the Role of no Gastric Residual ASSessment and Standard Gastric Residual Measurement for the Achievement of Full Enteral Feeding in Preterm Infants
NCT number | NCT03111329 |
Other study ID # | GRASS-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 6, 2017 |
Est. completion date | July 30, 2021 |
Verified date | May 2024 |
Source | Institute for the Care of Mother and Child, Prague, Czech Republic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study aims to compare routine assessment of gastric residuals versus no assessment of residuals in preterm neonates with respect to time taken for achieving full enteral feeding and the incidence of possible complications, such as feeding intolerance, necrotizing enterocolitis, sepsis etc.
Status | Completed |
Enrollment | 95 |
Est. completion date | July 30, 2021 |
Est. primary completion date | July 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 26 Weeks to 30 Weeks |
Eligibility | Inclusion Criteria: - Preterm neonate, born between 26+0 and 30+0 weeks of gestation - Birth weight below 1500g - Parental informed consent obtained Exclusion Criteria: - Intrauterine growth retardation (birth weight below 5th centile for given gestational age and gender) - Life-threatening events requiring full resuscitation at the delivery room (severe hypoxia, bleeding), and persistently raised lactate value of more than 5 mmol/l - Circulatory instability requiring treatment with inotropes - Highly suspected early onset sepsis with alteration of general clinical state, in particular with worsened peripheral perfusion and circulatory decompensation prior to study begin (during the first 6 hours after admission to NICU) - Known malformations of gastrointestinal tract, known diagnosis of congenital diaphragmatic hernia, any other life-limiting serious congenital malformations |
Country | Name | City | State |
---|---|---|---|
Czechia | Institute for the Care of Mother and Child | Prague | |
Ireland | Coombe Women and Infants University Hospital | Dublin |
Lead Sponsor | Collaborator |
---|---|
Institute for the Care of Mother and Child, Prague, Czech Republic | Coombe Women and Infants University Hospital |
Czechia, Ireland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of days taken to achieve full enteral feeding (i.e. dose of 100ml/kg/day) | Time taken (in hours) to reach full enteral feeding, defined as overall dose of 100ml of feeds/kg of birth weight/ day | 5 days after delivery for yes or no answer to whether full enteral feeding has been achieved, thereafter daily for the first three weeks until full enteral feeding has been reached | |
Secondary | Withholding of enteral feeding | The need to withhold enteral feeds due to clinical situation as per clinical judgement of the clinician in charge | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | |
Secondary | Total duration of parenteral infusion | The length of time (in hours) that parenteral infusion is needed | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | |
Secondary | Total duration of indwelling central venous catheter | The length of time (in hours) that an indwelling central venous catheter is needed | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | |
Secondary | Hypoglycaemia | Any episodes of hypoglycaemia (value less than 2,5 mmol/l) after attainment of full enteral feeding | Through first (on average) two to three weeks of the study until full enteral feeding is achieved. | |
Secondary | Late onset sepsis | The incidence of late onset sepsis | Duration of hospitalization, an average of 8-15 weeks | |
Secondary | Necrotizing enterocolitis | The incidence of necrotizing enterocolitis | Duration of hospitalization, an average of 8-15 weeks | |
Secondary | Spontaneous intestinal perforation | The incidence of spontaneous intestinal perforation | Duration of hospitalization, an average of 8-15 weeks | |
Secondary | Bronchopulmonary dysplasia | Incidence of bronchopulmonary dysplasia | At timepoint of reached 36 gestational weeks of the neonate | |
Secondary | Intraventricular and periventricular haemorrhage | The incidence of intraventricular and periventricular haemorrhage (stage I-IV) | Duration of hospitalization, an average of 8-15 weeks | |
Secondary | Retinopathy of prematurity | Incidence of retinopathy of prematurity (stage I-V) | Duration of hospitalization, an average of 8-15 weeks | |
Secondary | Neurodevelopment | Assessment of neurodevelopmental outcome | Follow up at 24 months of corrected age of the child |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03670732 -
CPAP vs.Unsynchronized NIPPV at Equal Mean Airway Pressure
|
N/A | |
Completed |
NCT05322161 -
Yoga in the NICU for Parents Study
|
N/A | |
Recruiting |
NCT04542096 -
Real Time Evaluation of Dynamic Changes of the Lungs During Respiratory Support of VLBW Neonates Using EIT
|
||
Recruiting |
NCT04911452 -
Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants
|
N/A | |
Recruiting |
NCT02901652 -
NIPPV and nBiPAP Methods in Preterm Infants With Respiratory Distress Syndrome
|
N/A | |
Completed |
NCT02148965 -
Effects of Exercise During Pregnancy on Maternal and Child Health: a Randomized Clinical Trial
|
N/A | |
Terminated |
NCT02032511 -
Comparison of RAM Cannula Nasal Continuous Positive Airway Pressure Versus Infant Flow Nasal Continuous Positive Airway Pressure (NCPAP)
|
N/A | |
Completed |
NCT02273843 -
A Trial on Different Dosages of Vitamin D in Preterm Infants With Late-onset Sepsis
|
Phase 1 | |
Completed |
NCT01721629 -
Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants
|
N/A | |
Terminated |
NCT01819532 -
Milking the Umbilical Cord Versus Immediate Clamping in Pre-term Infants < 33 Weeks
|
N/A | |
Completed |
NCT01478711 -
Comprehensive Clinical Decision Support (CDS) for the Primary Care of Premature Infants
|
N/A | |
Completed |
NCT00951860 -
Assessment of Autonomic Maturation in Neonatal Period and Early Neural Development From a Longitudinal Prospective Cohort
|
N/A | |
Completed |
NCT01523769 -
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants
|
N/A | |
Completed |
NCT00787124 -
Transfusions and Nitric Oxide Level in Preterm Infants
|
||
Completed |
NCT00749008 -
Study of Generalized Movements for Early Prediction of Cerebral Palsy
|
N/A | |
Terminated |
NCT01208493 -
Dietary Protein in the Very-low-birth-weight Infant
|
N/A | |
Terminated |
NCT00486395 -
Will CPAP Reduce Length Of Respiratory Support In Premature Infants?
|
Phase 3 | |
Completed |
NCT00527956 -
Facilitation and Barriers to Breastfeeding in the NICU
|
N/A | |
Completed |
NCT03372590 -
NEO Rehab for Infants at Risk of Cerebral Palsy
|
N/A | |
Completed |
NCT00033917 -
Indomethacin Germinal Matrix Hemorrhage/Intraventricular Hemorrhage (GMH/IVH) Prevention Trial
|
Phase 3 |