NCT02886910

Brief Summary

This study evaluates the non-inferiority of a protocol of limited evaluation (complete blood count, blood culture) and clinical observation by standardized physical examination versus the algorithm suggested in the CDC's 2010 guidelines (limited evaluation, clinical observation and antibiotic therapy) in the management of asymptomatic infants born at term to mothers with suspected chorioamnionitis. The primary outcome of the study is the difference in the prevalence of sepsis-related symptoms between the two groups.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

July 12, 2019

Status Verified

July 1, 2019

Enrollment Period

3 years

First QC Date

August 29, 2016

Last Update Submit

July 10, 2019

Conditions

ChorioamnionitisEarly Onset Neonatal SepsisSepsis of the Newborn

Keywords

ChorioamnionitisEarly onset neonatal sepsisAntibioticsClinical observation

Outcome Measures

Primary Outcomes (1)

  • Sepsis-related signs and symptoms

    Presence of pale/cyanotic/mottled skin, respiratory rate higher than 60 breaths/minute or respiratory distress

    48 hours of life

Secondary Outcomes (4)

  • Mortality

    21 days

  • Neonatal intensive care unit admittance

    21 days

  • Days of antibiotics

    21 days

  • Days of hospitalization

    21 days

Study Arms (2)

Clinical observation

EXPERIMENTAL

Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. They will receive a limited evaluation (blood culture, complete blood count), and a clinical observation. Antibiotics will be started only if sepsis-related signs or symptoms are present.

Other: Clinical observation

Standard management

ACTIVE COMPARATOR

Asymptomatic newborns born at term to mothers with suspected chorioamnionitis. The will receive a limited evaluation (blood culture, complete blood count), a clinical observation and antibiotics at birth.

Other: Clinical observationOther: Standard management

Interventions

Clinical observationOTHER

Antibiotics will be started only if sepsis-related signs or symptoms are present.Clinical observation consists in a standardized physical examination protocol according to which newborns are observed by the nurses at 1, 2, 4, 8, 12, 16, 20, 24 hours of life and then every 6 hours up to 48 hours of life. The following signs and symptoms are checked: skin colour (pink/pale/cyanotic/mottled), respiratory rate (lower or higher than 60 breaths/minute) and presence or absence of respiratory distress.

Clinical observationStandard management
Standard managementOTHER

Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol

Standard management

Eligibility Criteria

Age10 Minutes - 6 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \- asymptomatic newborns born at term (\>= 37 weeks of gestational age)

You may not qualify if:

  • preterm newborns (\< 37 weeks gestational age)
  • sepsis-related signs of symptoms at birth
  • intensive care admittance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute for Maternal and Child Health IRCCS Burlo Garofolo

Trieste, Friuli Venezia Giulia, 34137, Italy

Location

MeSH Terms

Conditions

ChorioamnionitisNeonatal Sepsis

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFetal Membranes, Premature RuptureObstetric Labor ComplicationsPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesSepsisInfectionsInfant, Newborn, DiseasesSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Officials

  • Sergio Demarini, MD

    Institute for maternal and child health - IRCCS "Burlo Garofolo", Trieste, Italy

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

August 29, 2016

First Posted

September 1, 2016

Study Start

October 1, 2016

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

July 12, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)