Actively Recruiting

Phase Not Applicable
Age: 1Month - 11Years
All Genders
ID06224764

Assessment of the Impact of the Return Home of Premature Newborns With Intrauterine Growth Retardation Weighing Less Than 2 Kilos on Short- and Long-term Morbidity/Mortality

Led by Hôpital NOVO · Updated on 2025-01-03

40

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of discharging premature newborns weighing less than 2 kilograms from the hospital. The study focuses on both short-term and long-term outcomes for these infants who were treated at the NOVO hospital's neonatology department between 2012 and 2024. Prematurity and low birth weight are significant public health concerns, and advances in neonatal care along with parental involvement have reduced mortality rates among these vulnerable babies. Participants include premature newborns with intrauterine growth retardation discharged home weighing under 2 kilos. Data is collected through questionnaires completed by mothers and fathers, either on paper or by phone, covering the period from discharge until the baby reaches up to 11 months of age. The study also considers parental support and medical opinions regarding discharge weight criteria. During the study, researchers observe various health indicators including growth in weight, height, and head circumference, as well as morbidity and incidence of Sudden Unexplained Infant Death Syndrome (SUIDS). Parents' experiences and the support they receive are also assessed remotely. The main outcome is the short-term health status of these newborns at an average of 11 months post-discharge, with additional evaluations at around 6 months. Participation involves completing questionnaires and data collection related to the infant's health and development.

CONDITIONS

Brief Title

Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality

Who Can Participate

Age: 1Month - 11Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Premature newborn born before 37 weeks of gestation
  • Newborn with intrauterine growth retardation (IUGR)
  • Hospitalized in the neonatology department of NOVO hospital (Pontoise site)
  • Born between January 1, 2012, and December 31, 2024
  • Discharged home weighing less than 2 kilograms
  • Covered by a social security scheme or entitled person
Not Eligible

You will not qualify if you...

  • Newborn transferred to another hospital before discharge
  • Refusal by one of the parents to participate
  • Parent does not speak or understand French

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person or by phone)

Monitoring

Duration - Up to 11 months

Participants are observed through questionnaires and data collection on newborns weighing less than 2 kilos from discharge up to 11 months to assess growth, morbidity, and parental support.

Periodic remote questionnaires and data collection visits depending on participant availability

Trial Site Locations

Total: 1 location

1

Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site

Pontoise, France, 95300

Actively Recruiting

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Research Team

M

Maryline DELATTRE

M

Mathilde WLODARCZYK

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

OTHER

Number of Arms

1

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