Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality
ConditionPremature Birth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-11
SponsorHôpital NOVO
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Newborn transferred to another hospital before discharge.
Refusal by one of the parents.
Parent does not speak or understand French.
Trial design
Design model
Single group
Treatments tested in this trial
Mother and Father questionnaires
Other interventionMother and Father questionnaires (on paper or by phone) and data collectionon newborns weighing less than 2 kilos (at discharge from birth to 11 months)
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Mother and Father questionnairesOther 1 intervention
Trial outcomes
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).
Time frame
At the end of the study, an average of 11 monthSecondary outcomes
1
Observation of weight growth
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 month2
Observation of height growth
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 month3
Observation of the growth of the cranial perimeter
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 11 month4
Observation of morbidity associated with neonatal discharge at less than 2 kilos
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 6 monthSponsors and contacts
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Source ClinicalTrials.gov