NCT02865772

Brief Summary

The aim of this study to determine the reference ranges of LBC on gastric aspirate in healthy term newborns.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
248

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

August 12, 2016

Status Verified

August 1, 2016

Enrollment Period

1 month

First QC Date

August 2, 2016

Last Update Submit

August 9, 2016

Conditions

Infant, Newborn, Diseases

Outcome Measures

Primary Outcomes (1)

  • normal levels of lamellar body counts on gastric aspirate in healthy term newborns.

    2 months

Study Arms (1)

observational

healthy newborns

Eligibility Criteria

Age10 Minutes - 30 Minutes
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

healthy newborns

You may qualify if:

  • infants born at ≥ 37 weeks of gestation and birth weight ≥ 2500 g

You may not qualify if:

  • intubated immediately after birth, infants with respiratory distress, infants with gestational pathology that can influence fetal lung maturity (cases with premature rupture of membranes, preeclampsia/eclampsia, gestational diabetes, oligohydramnios/polyhidramnios or antenatal steroid use), infants with major congenital or chromosomal abnormalities and lack of parental consent, therapeutic infusion was given in the amniotic cavity or if gastric aspirate contaminated by meconium, pus or blood.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

gastric aspiration fluid

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 12, 2016

Study Start

November 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 12, 2016

Record last verified: 2016-08