NCT06224764

Brief Summary

The aim of this study is to evaluate the impact of discharge from hospital with a weight of less than 2 kilos. To do this, the investigator will look at the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the neonatology department at the NOVO hospital between 2012 and 2024.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

January 2, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 25, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

February 21, 2024

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

January 3, 2025

Status Verified

December 1, 2024

Enrollment Period

1.7 years

First QC Date

January 2, 2024

Last Update Submit

January 2, 2025

Conditions

Premature Birth

Keywords

PrematurityWeight at dischargeMorbi-mortalityNeonatology

Outcome Measures

Primary Outcomes (1)

  • Observation of the short-term outcome of neonates discharged from the neonatology department hospital (Pontoise site) between 2012 and 2024 with a weight of less than 2 kilos.

    The short-term outcom is observed with the number of newborns weighing less than 2 kilos readmitted to hospital 30 days after discharge from the neonatology department of the NOVO hospital (Pontoise site) between 01/01/2012 and 31/12/2024. This data will be obtained from the questionnaire sent to the child's parents (question number 9 - "At the time of discharge" section).

    At the end of the study, an average of 11 month

Secondary Outcomes (8)

  • Observation of weight growth

    At the end of the study, an average of 11 month

  • Observation of height growth

    At the end of the study, an average of 11 month

  • Observation of the growth of the cranial perimeter

    At the end of the study, an average of 11 month

  • Observation of morbidity associated with neonatal discharge at less than 2 kilos

    At the end of the study, an average of 6 month

  • Observation of the incidence of Sudden Unexplained Infant Death Syndrome (SUIDS)

    At the end of the study, an average of 11 month

  • +3 more secondary outcomes

Study Arms (1)

Mother and Father questionnaires

OTHER

Mother and Father questionnaires (on paper or by phone) and data collectionon newborns weighing less than 2 kilos (at discharge from birth to 11 months)

Other: Mother and Father questionnaires

Interventions

Mother and Father questionnairesOTHER

Mother and Father questionnaires (on paper or by phone) and data collectionon newborns weighing less than 2 kilos (at discharge from birth to 11 months)

Mother and Father questionnaires

Eligibility Criteria

Age1 Month - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Premature newborn baby (born at less than 37 days' gestation)
  • Newborn baby with IUGR (Intra-Uterine Growth Retardation)
  • Newborn baby hospitalised in the neonatology department of the NOVO hospital - Pontoise site
  • Patient born between 01/01/2012 and 31/12/2024.
  • Newborn who has left the neonatology department or the Kangaroo Unit to return home weighing less than 2 kg.
  • Newborn beneficiary of a social security scheme or entitled person.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site

Pontoise, 95300, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Dr Suzanne BORRHOMEE

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryline DELATTRE

CONTACT

+3333130754131maryline.delattre@ght-novo.fr

Mathilde WLODARCZYK

CONTACT

+3333130754040mathilde.wlodarczyk@ght-novo.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Mother and Father questionnaires (on paper or by phone).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2024

First Posted

January 25, 2024

Study Start

February 21, 2024

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

January 3, 2025

Record last verified: 2024-12

Locations

FR(1)