Timing of inguinal hernia repair in premature infants: A randomized trial

Conditions: groin hernia
Inguinal hernia
10041297

Registration Number: NL-OMON47652

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

1) gestational age (GA)<37 weeks
2) diagnosed with inguinal hernia by pediatric surgeon
3) diagnosed during hospital stay
4) Parental informed consent

Exclusion Criteria

1) Infant is undergoing another operative procedure and IH repair is planned as a secondary procedure
2) Associated factor impacts timing of IH repair
3) Known major congenital anomaly or chromosomal abnormality (specified in protocol)
4) Family unable / unwilling to return for follow up or are not willing to participate if the patient is randomized for late IH repair;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome measure is the proportion of infants with * 1 Serious<br /><br>Adverse Event (SAE), measured from enrolment through 10 months after<br /><br>enrolment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Compare the overall safety of early and late IH repair with respect to<br /><br>neurodevelopmental outcome assessed with intra-operative measurements and at<br /><br>22-26 months corrected age (at selected sites with well-established follow up<br /><br>programs).<br /><br>2. Using Bayesian and frequentist analyses, evaluate specific hypotheses about<br /><br>patient characteristics that may influence the relative safety of early and<br /><br>late IH repair.<br /><br>3. To conduct the HIP Trial in an exemplary manner and thereby promote the<br /><br>newly established American pediatric Surgery Research Collaborative (pedSRC) as<br /><br>an ongoing research network</p><br>