Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02899819
Other study ID # PI10-PR-BACH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2011
Est. completion date February 2015

Study information

Verified date August 2018
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The MecoExpo project seeks to evaluate the in utero exposure of newborns in the Picardie region to commonly used pesticides. These pesticides were selected in a pilot study (the Mecopic study) on the basis of their toxicity (effects on foetal development, endocrine perturbation, neurological toxicity and carcinogenicity) and a certain number of indicators of pesticide use and the presence of pesticide in the environment in Picardie.

These substances (or their metabolites) will be measured in the each newborn's meconium (the first faeces after birth) and each newborn's mother's hair in the Picardie region during the study period. The mother's exposure will also be assessed using a retrospective questionnaire (filled out within a few days of the delivery).

Thus, the MecoExpo project will enable the investigators to:

1. evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and clinical parameters measured at birth (term, length, weight, etc.).

2. map pesticide exposure across the Picardie region.

3. create a meconium bank in Picardie (the first ever meconium bank in France).


Recruitment information / eligibility

Status Completed
Enrollment 1020
Est. completion date February 2015
Est. primary completion date February 2015
Accepts healthy volunteers No
Gender All
Age group N/A to 2 Days
Eligibility Inclusion Criteria:

- All newborns in Picardie will be eligible. Good command of the French language by a least one of the two people with responsibility for the child will be required for filling out the questionnaire.

- The mother's place of residence must have been in Picardie during the last two trimesters of pregnancy.

Exclusion Criteria:

- Newborns with foetal distress

Study Design


Related Conditions & MeSH terms


Intervention

Other:
meconium
The meconium will be sampled in the first 2 days of life

Locations

Country Name City State
France CH Abbeville Abbeville
France CHU Amiens Amiens
France Groupe Santé Victor Pauchet Amiens
France CH Beauvais Beauvais
France CH Chateau-Thierry Chateau-thierry
France CH Chauny Chauny
France CH Compiegne Compiegne
France Clinique Saint Come Compiegne
France Groupe Hospitalier Public Sud Oise Creil
France CH Laon Laon
France CH Peronne Peronne

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary fœtal vs mother exposure - term evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and term at birth Day 2
Primary fœtal vs mother exposure - length evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and length at birth Day 2
Primary fœtal vs mother exposure - weight evaluate the relationships between foetal exposure (via the meconium), maternal exposure (via the hair and the questionnaire) and weight at birth Day 2
See also
  Status Clinical Trial Phase
Completed NCT04994652 - Video- Or Direct Laryngoscopy for Endotracheal Intubation in Newborns N/A
Completed NCT02064712 - Determining an Optimal Weaning Method of Nasal Continuous Positive Airway Pressure in Preterm Neonates N/A
Withdrawn NCT01335919 - Neonatal Non-Invasive Hemoglobin Determination N/A
Terminated NCT01192776 - Optimizing (Longer, Deeper) Cooling for Neonatal Hypoxic-Ischemic Encephalopathy(HIE) N/A
Completed NCT00114543 - Trial of Aggressive Versus Conservative Phototherapy in Infants <1,000 Grams Birth Weight Phase 3
Completed NCT00011362 - Dexamethasone Therapy in VLBW Infants at Risk of CLD Phase 3
Recruiting NCT05001334 - Effect of Kangaroo Care on Phyiological Weight Loss in Term Newborns N/A
Completed NCT01193270 - Vitamin E for Extremely Preterm Infants Phase 1
Completed NCT00005772 - Whole-Body Cooling for Birth Asphyxia in Term Infants Phase 3
Terminated NCT00005776 - Inhaled Nitric Oxide Study for Respiratory Failure in Newborns Phase 3
Completed NCT01203423 - Persistent Pulmonary Hypertension of the Newborn (PPHN) Observational Study
Completed NCT06120062 - Effect of Swaddling and Inhaling Breast Milk Odour on the Pain and Comfort
Completed NCT00820677 - Newborn Health Information Study N/A
Active, not recruiting NCT00189384 - Efficacy Study of Community-Based Treatment of Serious Bacterial Infections in Young Infants Phase 3
Completed NCT01203410 - Prediction of Jaundice in Term Infants
Recruiting NCT03745963 - The Influence of Skin-to-skin Contact on Cortical Activity During Painful Procedures on Preterm Infants in the NICU Phase 3
Completed NCT04050384 - Effect of a Vibratory Stimulus on Mitigating Nociception-specific Responses to Skin Puncture in Neonates N/A
Completed NCT01793129 - Preemie Hypothermia for Neonatal Encephalopathy N/A
Withdrawn NCT00598429 - Inhaled PGE1 in Neonatal Hypoxemic Respiratory Failure Phase 2
Completed NCT01223287 - Physiologic Definition of Bronchopulmonary Dysplasia N/A