After NEC

After necrotizing enterocolitis in preterm infants: The time to reach full enteral feeding and its relation to intestinal recovery and neurocognitive development.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22150

Enrollment

Registered

2014-09-25

Start date

2014-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

necrotizing enterocolitis

Interventions

none: observational

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: Infants with a gestational age Bells stage 1, admitted on the NICU in Groningen.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Large chromosomal abnormalities - Intraventricular hemorrhage/Perventricular hemorrhage >grade 2 - Use of dexamethason - Congenital heart deformities other than patent ductus arteriosus - Abdominal wall defects/other congenital gastroenteral deformities (ie atresia, microcolon) - Parents/caretakers who are unable to understand Dutch or English

Design outcomes

Primary

Measure	Time frame
Our main study parameters are based on the following questions: - Intestinal oxygen saturation (and extraction) measured with NIRS and the time it takes to reach full enteral feeding after developing NEC - The measurement of urinary I-FABPs and the time it takes to reach full enteral feeding after developing NEC - The measurement of plasma citrulline and the time it takes to reach full enteral feeding after developing NEC Our main study parameters consist of: -Intestinal oxygen saturation (rintSO2) -Intestinal FTOE -Concentration of urinary I-FABP -Plasma Citrulline levels	—

Measure

Time frame

Our main study parameters are based on the following questions: - Intestinal oxygen saturation (and extraction) measured with NIRS and the time it takes to reach full enteral feeding after developing NEC - The measurement of urinary I-FABPs and the time it takes to reach full enteral feeding after developing NEC - The measurement of plasma citrulline and the time it takes to reach full enteral feeding after developing NEC Our main study parameters consist of: -Intestinal oxygen saturation (rintSO2) -Intestinal FTOE -Concentration of urinary I-FABP -Plasma Citrulline levels

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Secondary

Measure	Time frame
Our second objective is to assess the relation between the time it takes to reach full enteral feeding (more or less than 10 days) after developing NEC and neurodevelopmental outcome measured with the assessment of the quality of GMs (and the calculation of the motor-optimality score) at the term and three months post term age. The study parameter to answer our second objective is: - Quality of general movements (motor-optimality score)	—

Measure

Time frame

Our second objective is to assess the relation between the time it takes to reach full enteral feeding (more or less than 10 days) after developing NEC and neurodevelopmental outcome measured with the assessment of the quality of GMs (and the calculation of the motor-optimality score) at the term and three months post term age. The study parameter to answer our second objective is: - Quality of general movements (motor-optimality score)

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Contacts

Public ContactE.M.W. Kooi

e.kooi@umcg.nl050-3614215

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)