Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mother and Father questionnaires.
- Who it may be relevant to
- Registry conditions: Premature Birth. Basic parameters: 1 months — 11 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other 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)
Primary outcome measures
- 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. [Time frame: At the end of the study, an average of 11 month]
Secondary outcome measures (8)
- Observation of weight growth [Time frame: At the end of the study, an average of 11 month]
- Observation of height growth [Time frame: At the end of the study, an average of 11 month]
- Observation of the growth of the cranial perimeter [Time frame: At the end of the study, an average of 11 month]
- Observation of morbidity associated with neonatal discharge at less than 2 kilos [Time frame: At the end of the study, an average of 6 month]
- Observation of the incidence of Sudden Unexplained Infant Death Syndrome (SUIDS) [Time frame: At the end of the study, an average of 11 month]
- Remote observation of parents' experiences [Time frame: At the end of the study, an average of 6 month]
- Observation of the support offered to parents [Time frame: At the end of the study, an average of 6 month]
- Description of medical positions on minimum discharge weight [Time frame: At the end of the study, an average of 6 month]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
France · 1 center
- Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site — Pontoise
Identifiers
NCT: NCT06224764 · CHRD1722 · 2023-A02200-45