Amniotic Fluid For Enteral Nutrition (AFFEN) in newborn infants with congenital diaphragmatic hernia and esophageal/intestinal atresia

Not Applicable

Recruiting

Conditions: Q79.0
Q41
Q39.0
Q39.1
Q40
Congenital diaphragmatic hernia
Congenital absence, atresia and stenosis of small intestine
Atresia of oesophagus without fistula
Atresia of oesophagus with tracheo-oesophageal fistula
Other congenital malformations of upper alimentary tract

Registration Number: DRKS00025534

Lead Sponsor: Abteilung Neonatologie und Pädiatrische Intensivmedizin, Zentrum für Kinderheilkunde, ELKI, Universitätsklinikum Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Patients who meet the following criteria will be enrolled in the study:
• Presence of parental consent
• Newborns with prenatal known congenital diaphragmatic hernia or esophageal/intestinal atresia
• Newborns with above-mentioned indication and delivery in university hospital bonn (UKB) (If possible with amniotic fluid collection, otherwise comparison group)
• Newborns with above-mentioned indication and but delivery extern of the UKB (Due to the lack of amniotic fluid collection as a comparison group)

Exclusion Criteria

Patients who meet one of the following criteria will be excluded in the study:
• Amniotic infection syndrome
• Severe cardiorespiratory problems, which prevent surgical correction of the malformation and thus prevent enteral nutritional buildup

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main goal: To accelerate enteral nutrition buildup with postoperative enteral amniotic feeding in neonates with diaphragmatic hernia and esophageal/intestinal atresia.<br><br>Primary Outcome: Time of enteral food buildup up to 100 ml/kg bw/d

Secondary Outcome Measures

Name	Time	Method
Secondary goal: Examination whether amniotic fluid:<br>1. Facilitates the start of enteral nutrition and shortens the parenteral nutrition period <br>2. promotes intestinal development and maturation, thus increasing food tolerance<br>3. components can be correlated with the clinical development of the patients<br>4. and has an effect of the microbiome.<br><br>Endpunkte:<br>1. Start of the food buildup (with mother milk or formula nutrition) in days of life<br>2. Qualitative and quantitative study of various growth factors of the amniotic fluid and correlation with the start of food build-up<br>3. Weight gain; Occurrence of cholestasis, sepsis, bronchopulmonary dysplasia or gastrointestinal complications such as necrotizing enterocolitis.<br>4. Composition of the microbiome in meconium, in feces after surgery, and feces at an enteral food buildup of 100 ml/kg bw/d