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

NCT ID: NCT06224764

Last Updated: 2025-01-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-21
• Study Completion Date: 2025-11-30

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.

Detailed Description

Prematurity in itself, whether simple or associated with intrauterine growth retardation, continues to be a real public health problem. In addition to gestational age at birth, the presence of co-morbidities can affect the morbidity and mortality of premature babies, as well as the length of hospital stay.

Advances in neonatal care and the involvement and skills of parents in the care of premature infants have led to a considerable reduction in mortality among these patients. According to the latest recommendations published in November 2022 by the WHO, and thanks to changes in the criteria for discharging these patients in recent years, the same applies to low-birthweight infants.

The early and well-planned discharge of premature babies is currently the subject of a great deal of study and research. According to these studies, it has been shown that the essential criteria for this discharge are the physiological capacities and skills of these vulnerable patients (thermoregulation, autonomous feeding and breathing, etc.). Essential care, parental support and home visits by qualified health workers (PMI, HAD, etc.) are also essential.

Premature birth has a real impact on the economic consequences in several countries. Infants small for gestational age had longer hospital stays, were more likely to be admitted to an intensive care unit and were more likely to be hospitalised in the first year of life, resulting in higher costs.

It is against this backdrop that the NOVO hospital is proposing to evaluate the impact of discharging babies weighing less than 2 kilos. To do this, the investigator will base his study on the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the NOVO hospital's neonatology department between 2012 and 2024.

Conditions

Premature Birth

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Mother and Father questionnaires

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)

Group Type: OTHER

Mother and Father questionnaires

Intervention Type: 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)

Interventions

Mother and Father questionnaires

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital NOVO

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Suzanne BORRHOMEE

Role: PRINCIPAL_INVESTIGATOR

Hôpital NOVO

Locations

Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site

Pontoise, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Maryline DELATTRE

Role: CONTACT

maryline.delattre@ght-novo.fr

+3333130754131

Mathilde WLODARCZYK

Role: CONTACT

mathilde.wlodarczyk@ght-novo.fr

+3333130754040 ext. 7199

Facility Contacts

Dr Suzanne BORRHOMEE

Role: primary

suzanne.borrhomee@ght-novo.fr

+33 1 30 75 50 32

Dr Rayane MAHFOUZ

Role: backup

rayane.mahfouz@gmail.com

+33 1 30 75 50 32

Other Identifiers

2023-A02200-45

Identifier Type: OTHER

Identifier Source: secondary_id

CHRD1722

Identifier Type: -

Identifier Source: org_study_id