Clinical trial NCT06224764: Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality
Official title: Assessment of the Impact of the Return Home of Premature Newborns With Intrauterine Growth Retardation Weighing Less Than 2 Kilos (Low Birth Weight) on Short- and Long-term Morbidity/Mortality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature Birth
Keywords: Prematurity
Weight at discharge
Morbi-mortality
Neonatology
Lead sponsor: Hôpital NOVO
Sponsor class: OTHER
First posted: 2024-01-25
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Mother and Father questionnaires (on paper or by phone).
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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.
timeFrame: At the end of the study, an average of 11 month
Secondary outcomes:
measure: Observation of weight growth
timeFrame: At the end of the study, an average of 11 month
measure: Observation of height growth
timeFrame: At the end of the study, an average of 11 month
measure: Observation of the growth of the cranial perimeter
timeFrame: At the end of the study, an average of 11 month
measure: Observation of morbidity associated with neonatal discharge at less than 2 kilos
timeFrame: At the end of the study, an average of 6 month
measure: Observation of the incidence of Sudden Unexplained Infant Death Syndrome (SUIDS)
timeFrame: At the end of the study, an average of 11 month
measure: Remote observation of parents' experiences
timeFrame: At the end of the study, an average of 6 month
measure: Observation of the support offered to parents
timeFrame: At the end of the study, an average of 6 month
measure: Description of medical positions on minimum discharge weight
timeFrame: At the end of the study, an average of 6 month
Other outcomes:
Locations:
city: Pontoise
country: France
facility: Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site
Study officials:
affiliation: Hôpital NOVO
name: Dr Suzanne BORRHOMEE
role: PRINCIPAL_INVESTIGATOR
References: