Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site
Pontoise, 95300, France
Location status: Recruiting
Location contact
Dr Rayane MAHFOUZ
CONTACT
Dr Suzanne BORRHOMEE
CONTACT
NCT Number: NCT06224764
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.
Interested in participating?
Request Info1 month–11 year
All sexes
Interventional
Not applicable
Pontoise, 95300, France
Location status: Recruiting
Dr Rayane MAHFOUZ
CONTACT
Dr Suzanne BORRHOMEE
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: At the end of the study, an average of 11 month
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).
Time frame: At the end of the study, an average of 11 month
Z-score measurement for weight. Measured at systematic visits at 2 months, 4 months and 11 months.
Time frame: At the end of the study, an average of 11 month
Z-score measurement for height. Measured at systematic visits at 2 months, 4 months and 11 months.
Time frame: At the end of the study, an average of 11 month
Z-score measurement for cranial perimeter. Measured at systematic visits at 2 months, 4 months and 11 months.
Time frame: At the end of the study, an average of 6 month
The morbidity is observed with the number of newborns with the following morbidities at 6 months post-discharge: digestive disorders (GERD, constipation, colic, blood in stools), feeding difficulties, bronchiolitis, infant asthma, hospital admissions and emergency room visits for all reasons, poor weight gain, secondary infection (questions number 10 and 11 in the questionnaire).
Time frame: At the end of the study, an average of 11 month
Number of Sudden Unexplained Infant Deaths Syndrome (SUIDs) at 11 months from discharge (question number 14) when the parent questionnaire is returned, supplemented by a call from the investigator to the parents if the patient has died, in order to find out whether he or she has suffered a Sudden Unexplained Infant Death Syndrome (SUIDS). This information will also be sought in the patient's medical records.
Time frame: At the end of the study, an average of 6 month
Description of parental stress and worries about returning home, studied using a questionnaire created for the research and given to parents (stress before discharge: questions number 4, 7, 9 and 10 of the questionnaire, stress on returning home: questions number 7 and 13).
Time frame: At the end of the study, an average of 6 month
Description of the type of follow-up (HAH nurse, referring doctor, Day Hospital follow-up) organised on discharge This information will be obtained from the questionnaire asked of the parents of the patients concerned (question number 3 on return).
Time frame: At the end of the study, an average of 6 month
Description of medical positions on minimum discharge weight, via a questionnaire sent to doctors in various neonatal intensive care units/paediatric intensive care units in the Paris region (questions number 12, 13, 14 and 15).
Contact information is provided by the study sponsor or research team.
Hôpital NOVO
Other
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
Acronym: Petit-Poids
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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