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.
Study Type
OBSERVATIONAL
Enrollment
200
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.
Górnośląskie Centrum Zdrowia Dziecka, Szpital Uniwersytecki ŚUM, Klinika Chirurgii Dziecięcej i Urologii Dziecięcej
Katowice, Poland
Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu, Oddział Ginekologiczno-Położniczy, Pododdział Rozrodczości i Medycyny Perinatalnej
Poznan, Poland
Szpital Kliniczny Uniwersytetu Medyczny w Poznaniu, Klinika Chirurgii Traumatologii i Urologii Dziecięcej
Poznan, Poland
Szpital Miejski w Rudzie Śląskiej, Katedra i Oddział Kliniczny Ginekologii i Położnictwa, Wydziału Nauk o Zdrowiu
Ruda Śląska, Poland
Kliniczny Szpital Wojewódzki nr 2 im. Świętej Jadwigi Królowej. Klinika Położnictwa Ginekologii i Perinatologii
Rzeszów, Poland
Szpital Wojewódzki Nr 2 im. Św. Jadwigi Królowej w Rzeszowie, Klinika Chirurgii Dziecięcej
Rzeszów, Poland
Uniwersyteckie Centrum Kliniczne WUM, Dziecięcy Szpital Kliniczny. Klinika Chirurgii i Urologii Dziecięcej i Pediatrii
Warsaw, Poland
Instytut Matki i Dziecka
Warsaw, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego. Klinika Położnictwa, Perinatologii, Ginekologii i Rozrodczości
Warsaw, Poland
The prevalence of different forms of GS
The prevalence of different forms of GS: simple, complex
Time frame: During primary surgery
Agreement rate between prenatal and neonatal assessment of the bowel condition
Comparison of the prenatal ultrasound bowel condition and the newborn's bowel assessment by the surgeon
Time frame: Prenatal assessment - during every US examination up to the time of delivery; newborn's evaluation - during primary surgery
Prevalence of necrotizing enterocolitis (NEC)
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.
Time frame: Up to 28 days after birth
Prevalence of short bowel syndrome (SBS)
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
Time frame: During primary surgery or reoperation
Prevalence of newborn sepsis
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 frame: Up to 28 days after birth
Time to full enteral feeding (TFEF)
Time to full enteral feeding (TFEF) - the time when neonates start to receive all of their prescribed nutrition as milk feeds
Time frame: From date of birth until the first day when full enteral feeding is achieved, assessed up to 28 days after birth.
Duration of the total parenteral nutrition (TPN)
Total Parenteral Nutrition (TPN) - duration of parenteral nutrition, the time of intravenous feeding of nutritional products
Time frame: From the first day of TPN initiation until the last day of TPN administration, assessed up to 28 days after birth.
Time to start enteral feeding (TSEF)
Time to start enteral feeding (TSEF) - the time when neonates start enteral nutrition
Time frame: From date of birth until the first day enteral feeding is initiated, assessed up to 14 days after birth.
Time to start oral feeding (TSOF)
Time to start oral feeding (TSOF)- the time when neonates start oral feeding
Time frame: From date of birth until the first day of oral feeding initiation, assessed up to 28 days after birth.
Time to full oral feeding (TFOF)
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)
Time frame: From date of birth until the first day full oral feeding is achieved, assessed up to 28 days after birth.
Lenght of hospital stay (LOS)
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
Time frame: Time from the newborn's birth to discharge from the hospital, up to 28 days after birth
Prevalence of modes of delivery
Mode of delivery - method of pregnancy termination: vaginal delivery or cesarean delivery
Time frame: At delivery
Duration of pregnancy
Duration of pregnancy \[days\]
Time frame: At delivery
Time to repair (primary surgery)
Time to repair (primary surgery); even primary closure or SILO \[hours\]
Time frame: From date and time of birth until the start of the primary surgical repair, up to 28 days after birth
Time to closure abdominal wall defect
Time to abdominal wall defect closure, even primary or secondary \[hour\]
Time frame: From date and time of birth until the completion of definitive abdominal wall defect closure, up to 28 days after birth
Prevalence of neonatal death
Neonatal death within the first 28 days of life
Time frame: Up to 28 days after birth
Prevalence of intrauterine death
Intrauterine death after 22 gestational weeks
Time frame: After 22 gestational weeks
Prevalence of gastroschis types by Perrone et al. 2018
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
Time frame: During primary surgery, up to 28 days after birth
GPS (gastroschisis prognostic score) score by Cowan et al. 2012
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
Time frame: During primary surgery, up to 28 days after birth
Prevalence of Adverse Ultrasound Signs (AUS)
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.
Time frame: During every prenatal ultrasound examination, up to the time of delivery
Prevalence of Fetal Growth Restriction (FGR)
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.
Time frame: Assessed throughout pregnancy, up to the time of delivery
Prevalence of Composite Intestinal Complications (CIC)
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
Time frame: Up to 28 days after birth
Prevalence of bowel matting
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
Time frame: During primary surgery, up to 28 days after birth
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