Gastroschisis
Conditions
Keywords
gastroschisis, ORPHA:2368, congenital anomaly, MEGA Study, Observational study, Epidemiology, Prenatal diagnosis, Multicenter study, prenatal ultrasound
Brief summary
The purpose of this observational study is to evaluate selected epidemiological aspects of gastroschisis (GS) and factors affecting health outcomes of newborns with this diagnosis in a population of fetuses with gastroschisis. The main questions the study aims to answer are: * Are there correlations between the parameters of ultrasound evaluation of the bowel with the condition of the newborn's bowel as assessed by the surgeon? * What is the prevalence of the different forms of GS (classification according to the methodology of Molik et al. 2002, Perrone et al. 2018)? * What is the incidence of perioperative and postoperative complications and other complications of the neonatal period? * What is the relationship between the form of the defect (simple GS vs complex GS) and feeding milestones - TFEF, TPN, TSEF, TSOF, TFOF? * What is the relationship between clinical parameters, diagnostic and therapeutic management, including method and timing of delivery, and final outcomes? Participants will not perform any active tasks or receive interventions as part of this study. Data will be collected passively from historical medical records including prenatal test results, details of pregnancy, delivery, and postnatal information on the newborn's treatment. The information collected will be anonymized. The study aims to collect information on prenatal diagnosis and neonatal outcomes, analyze factors affecting final results, and develop the most optimal management regimen for GS in Poland.
Interventions
OTHERGastroschisis
Gastroschisis (GS) is a congenital abdominal wall defect in which the intestine is located outside the abdominal cavity. The prevalence of the GS classifies it as a rare disease (ORPHA:2368) Pregnancy complicated by gastroschisis is associated with an increased risk of serious perinatal complications. The presence of accompanying intestinal anomalies (atresia, necrosis, perforation, and volvulus), which qualifies the defect in the cGS (complex gastroschisis) group, as opposed to sGS (simple gastroschisis), where these anomalies are absent. cGS is associated with significantly increased neonatal morbidity and mortality when compared to sGS.
Sponsors
ResearchSkills
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* A fetus with a diagnosis of gastroschisis; * Availability of prenatal, delivery and postnatal records (for hospital discharge, transfer to another facility or death).
Exclusion criteria
* pregnancies terminated before the 22nd week of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The prevalence of different forms of GS | During primary surgery | The prevalence of different forms of GS: simple, complex |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of necrotizing enterocolitis (NEC) | Up to 28 days after birth | Diagnosis of necrotizing enterocolitis (NEC) is based on sudden onset of feeding intolerance, abdominal distention, bloody stools, and signs of sepsis (i.e., changes in the heart rate, respiratory rate, temperature, and blood pressure) in preterm infants, according to the Bell scale, which integrates the clinical and radiological manifestations. |
| Prevalence of short bowel syndrome (SBS) | During primary surgery or reoperation | Diagnosis of short bowel syndrome (SBS) is in case of loss of bowel length or function significantly enough to cause malabsorption, requiring lifelong parenteral support |
| Prevalence of newborn sepsis | Up to 28 days after birth | Newborn sepsis - an infection involving the bloodstream in infants under 28 days old. The clinical syndrome with symptomatology and laboratory findings consistent with a systemic inflammatory response to a multimodal infection caused by bacteria viruses, fungi potentially leading to multiple organ dysfunction, failure and even death within the first 28 days of life. |
| Time to full enteral feeding (TFEF) | From date of birth until the first day when full enteral feeding is achieved, assessed up to 28 days after birth. | Time to full enteral feeding (TFEF) - the time when neonates start to receive all of their prescribed nutrition as milk feeds |
| Duration of the total parenteral nutrition (TPN) | From the first day of TPN initiation until the last day of TPN administration, assessed up to 28 days after birth. | Total Parenteral Nutrition (TPN) - duration of parenteral nutrition, the time of intravenous feeding of nutritional products |
| Time to start enteral feeding (TSEF) | From date of birth until the first day enteral feeding is initiated, assessed up to 14 days after birth. | Time to start enteral feeding (TSEF) - the time when neonates start enteral nutrition |
| Time to start oral feeding (TSOF) | From date of birth until the first day of oral feeding initiation, assessed up to 28 days after birth. | Time to start oral feeding (TSOF)- the time when neonates start oral feeding |
| Time to full oral feeding (TFOF) | From date of birth until the first day full oral feeding is achieved, assessed up to 28 days after birth. | Time to full oral feeding (TFOF) - the time to achieve oral exclusive feeding, without using additional or alternative feeding methods (such as gavage or nasogastric tube) |
| Lenght of hospital stay (LOS) | Time from the newborn's birth to discharge from the hospital, up to 28 days after birth | Lenght of hospital stay (LOS) - duration of hospitalization - a clinical metric that measures the time elapsed between a patient's hospital admittance and discharge. For newborns - the time between the day of birth and its discharge |
| Prevalence of modes of delivery | At delivery | Mode of delivery - method of pregnancy termination: vaginal delivery or cesarean delivery |
| Agreement rate between prenatal and neonatal assessment of the bowel condition | Prenatal assessment - during every US examination up to the time of delivery; newborn's evaluation - during primary surgery | Comparison of the prenatal ultrasound bowel condition and the newborn's bowel assessment by the surgeon |
| Time to repair (primary surgery) | From date and time of birth until the start of the primary surgical repair, up to 28 days after birth | Time to repair (primary surgery); even primary closure or SILO \[hours\] |
| Time to closure abdominal wall defect | From date and time of birth until the completion of definitive abdominal wall defect closure, up to 28 days after birth | Time to abdominal wall defect closure, even primary or secondary \[hour\] |
| Prevalence of neonatal death | Up to 28 days after birth | Neonatal death within the first 28 days of life |
| Prevalence of intrauterine death | After 22 gestational weeks | Intrauterine death after 22 gestational weeks |
| Prevalence of gastroschis types by Perrone et al. 2018 | During primary surgery, up to 28 days after birth | Type A: ischemic bowel, significantly constricted at the ring without atresia Type B: ischemic bowel, significantly constricted at the ring (but viable) with an associated atresia Type C: ischemic bowel with a closing ring with nonviable external bowel (necrosis) with or without an associated atresia Type D: a completely closed defect with either a nubbin of exposed tissue or no external bowel |
| GPS (gastroschisis prognostic score) score by Cowan et al. 2012 | During primary surgery, up to 28 days after birth | GPS (gastroschisis prognostic score) based on bowel appearance in newborns (within 6 hours of birth) I. Bowel matting: 0 -none (normal bowel without inflammation) 1. mild (slight inflammation or with a visible plaque on the surface (mild bowel matting), always needs to expand (required widening) the abdominal wall defect during primary closure) 2. severe (moderate to massive inflammation with fibrous plaque (severe bowel matting) on the surface, stiffness of the intestinal wall EABL) II. Bowel atresia 0 - absent 1. \- suspected 2. \- present III. Bowel necrosis 0 - none 1. focal 2. \- diffuse IV. Bowel perforation 0 - none 2 - present |
| Prevalence of Adverse Ultrasound Signs (AUS) | During every prenatal ultrasound examination, up to the time of delivery | US 0-no adverse ultrasound signs: normal, stable, and adequate for the gestational age look of EABL (extra-abdominal bowel loops): normal bowel wall (non-hyperechoic, without oedema or/and thickening), free-floating loops without dilatation; no IABL (intra abdominal bowel loops) dilatation; no gastric dilatation. US 1-any ultrasound-adverse signs or progression: hyperechoic bowel wall or/and oedema or/and thickening; EABL dilatation; lack of lumen of EABL (collapsed bowel), non-free-floating loops with/or without bowel dilatation; IABL dilatation; gastric dilatation. |
| Prevalence of Fetal Growth Restriction (FGR) | Assessed throughout pregnancy, up to the time of delivery | Fetal Growth Restriction (FGR) - For early FGR (\< 32 weeks), three solitary parameters (abdominal circumference (AC) \< 3(rd) centile, estimated fetal weight (EFW) \< 3(rd) centile and absent end-diastolic flow in the umbilical artery (UA)) and four contributory parameters (AC or EFW \< 10(th) centile combined with a pulsatility index (PI) \> 95(th) centile in either the UA or uterine artery) were agreed upon. For late FGR (≥ 32 weeks), two solitary parameters (AC or EFW \< 3(rd) centile) and four contributory parameters (EFW or AC \< 10(th) centile, AC or EFW crossing centiles by \> two quartiles on growth charts and cerebroplacental ratio \< 5(th) centile or UA-PI \> 95(th) centile) were defined. Gordijn SJ, Beune IM, Thilaganathan B, Papageorghiou A, Baschat AA, Baker PN, Silver RM, Wynia K, Ganzevoort W. Consensus definition of fetal growth restriction: a Delphi procedure. Ultrasound Obstet Gynecol. 2016 Sep;48(3):333-9. doi: 10.1002/uog.15884. |
| Prevalence of Composite Intestinal Complications (CIC) | Up to 28 days after birth | Composite Intestinal Complications (CIC) - intestinal complication (atresia, necrosis, perforation, volvulus) resulting from the definition of complex gastroschisis and peri-/post-operative complications in both forms (sGS and cGS) of defect (post-closure reoperation, adhesion-related bowel obstruction, bowel resection, Ileostomy/colostomy, the requirement to improve bowel anastomosis |
| Prevalence of bowel matting | During primary surgery, up to 28 days after birth | Bowel matting: slight inflammation or with a visible plaque on the surface (mild bowel matting), always needs to expand (required widening) the abdominal wall defect during primary closure or moderate to massive inflammation with fibrous plaque (severe bowel matting) on the surface, stiffness of the intestinal wall EABL |
| Duration of pregnancy | At delivery | Duration of pregnancy \[days\] |
Countries
Poland
Outcome results
None listed