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Antibiotics and Gut Microbiota Among Newborn Infants

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ClinicalTrials.gov Identifier: NCT02072798
Recruitment Status : Completed
First Posted : February 27, 2014
Last Update Posted : August 12, 2014
Sponsor:
Collaborators:
University of Copenhagen
Aase and Ejnar Danielsens Foundation
Region of Southern Denmark
University of Southern Denmark
Information provided by (Responsible Party):
Nana Hyldig, Odense University Hospital

Tracking Information
First Submitted Date  ICMJE February 25, 2014
First Posted Date  ICMJE February 27, 2014
Last Update Posted Date August 12, 2014
Study Start Date  ICMJE February 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
  • Maternal: incidence of post-CS infection (endometritis, urinary tract infections and wound infection) in each study group [ Time Frame: Within the first 30 days after surgery ]
  • Infant: fecal microbiota at the tenth day of life [ Time Frame: on the tenth day of life ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02072798 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2014)
  • Maternal: Length of hospitalization [ Time Frame: Within the first 30 days after Caesarean Section ]
  • Maternal: readmissions to hospital on suspicion of postpartum infection following cesarean section [ Time Frame: Within the first 30 days after Caesarean Section ]
  • Antibiotic treatment [ Time Frame: within the first 30 days after Caesarean Section ]
  • Infant: concentration of cefuroxime in blood samples [ Time Frame: during the first 24 hours of life ]
  • Infant: immunological analyses in blood samples on day 3 [ Time Frame: On the third day of life ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Antibiotics and Gut Microbiota Among Newborn Infants
Official Title  ICMJE Antibiotic Prophylaxis for Postpartum Infections Following Caesarean Section
Brief Summary

Background Women undergoing Caesarean Section (CS) have an increased risk of postpartum infections compared to women undergoing vaginal delivery. In Denmark the incidence of post-CS infections is 7-10%. The most common infections are endometritis, Urinary tract infections (UTI) and wound infections (WI).

Prophylactic antibiotics are effective in preventing postoperative infections and national guidelines recommend that antibiotics should be administered as a single dose immediately before surgical incision. CS is an exception to this pre-incision administration approach. National guidelines recommend administration of antibiotics after umbilical cord clamping to avoid exposure of the child to antibiotics before birth. Recent studies of antibiotic prophylaxis for CS suggest that prophylactic antibiotics administered before incision compared to after umbilical cord clamping may reduce post-CS infections by up to 50%. Two Cochrane reviews from 2012 criticize these types of studies for lack of data for outcomes on the baby and on late infection in the mother.

At birth, all mammals must rapidly adapt to intake of complex milk nutrients via the gut and simultaneously tolerate the invasion of billions of microbes. This requires rapid maturation of the digestive and immune functions to avoid gut disorders and infections. Full-term, breast-fed infants normally adapt well, but factors such as caesarean birth, high hygiene levels, antibiotics treatment and formula feeding may inhibit immune development both short and long term. Birth by caesarean section in high-hygiene hospital environments, and widespread use of antibiotics, are factors that reduce gut microbiota density and diversity in the newborn for some time after birth. On the other hand, high-hygiene environments and antibiotics are essential tools to combat infections, especially for the weakest newborn infants.

This pilot study will be a feasibility study to the original study, which examines the effect of change in timing of prophylactic antibiotics on the rate of post-CS infections (endometritis, UTI and WI). The pilot study focus on antibiotic and changes in the gut microbiota of newborn infants. The feasibility study will only include pregnant women in Odense with a body mass index below 30, and planned cesarean section.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgical Wound Infection
  • Infection; Cesarean Section
  • Complications; Cesarean Section
Intervention  ICMJE Drug: Cefuroxime
iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
Other Name: Cefuroxime "Fresenius Kabi"
Study Arms  ICMJE
  • Active Comparator: preoperative antibiotic
    iv Cefuroxime 1,5g administered 15-60 minutes before incision
    Intervention: Drug: Cefuroxime
  • Active Comparator: postoperative antibiotic
    iv Cefuroxime 1,5g administered after umbilical cord clamping
    Intervention: Drug: Cefuroxime
Publications * Kamal SS, Hyldig N, Krych Ł, Greisen G, Krogfelt KA, Zachariassen G, Nielsen DS. Impact of Early Exposure to Cefuroxime on the Composition of the Gut Microbiota in Infants Following Cesarean Delivery. J Pediatr. 2019 Jul;210:99-105.e2. doi: 10.1016/j.jpeds.2019.03.001. Epub 2019 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 10, 2014)
42
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2014)
40
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 year
  • Women, who can read and understand Danish
  • A gestational age ≥ completed 28 weeks of gestation
  • Rupture of membranes and active labour (uterine contractions) is allowed.
  • BMI < 30

Exclusion Criteria:

  • Hypersensitivity to cefuroxime or to any other cephalosporin antibiotics
  • Previous immediate and/or severe hypersensitivity reaction to penicillin or any other beta-lactam antibiotic.
  • Systemic exposure to any antibiotic agent within 1 week before delivery Antibiotic indicated due to PROM, fever, group B Streptococcus or other indications at the time of caesarean section.
  • Women being immunologically incompetent (e.g. HIV positive)
  • Very sick newborn infants transferred to a neonatal intensive care unit and treated with antibiotics will be excluded from the study
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02072798
Other Study ID Numbers  ICMJE s-20130117
2012-002068-29 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nana Hyldig, Odense University Hospital
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE
  • University of Copenhagen
  • Aase and Ejnar Danielsens Foundation
  • Region of Southern Denmark
  • University of Southern Denmark
Investigators  ICMJE
Study Chair: Nana Hyldig, PhD student Odense University Hospital, department of Plastic Surgery, University of Southern Denmark, Faculty of Health Sciences, institute of Clinical Research, research unit, department of Gynaecology and Obstetrics
PRS Account Odense University Hospital
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP