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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00025534

Enrollment

Registered

2021-06-18

Start date

2021-01-21

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Q79.0 Q41 Q39.0 Q39.1 Q40

Interventions

Group 1: Intervention group: Newborns with Congenital diaphragmatic hernia, intestinal and esophageal atresia in whom we were able to collect sufficient amniotic fluid ntervention: Enteral nutrition b

Eligibility

Sex/Gender

All

Age

No minimum to 3 Days

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Measure

Time frame

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

—

Countries

Germany

Contacts

Public ContactSoyhan Bagci

Ärztlicher Leiter Kindernotfallzentrum Allgemeine Pädiatrie, Eltern-Kind-Zentrum (ELKI) Universitätsklinikum Bonn

soyhan.bagci@ukbonn.de+49 228 287 37227

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026