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

Premature Birth Clinical Trial

— Petit-Poids  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06224764
• Other study ID #: CHRD1722
• Secondary ID: 2023-A02200-45
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Hôpital NOVO
• Contact: Maryline DELATTRE
• Phone: +3333130754131
• Email: maryline.delattre[@]ght-novo.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 2023.

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 2023.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Months to 11 Years

Eligibility

Inclusion Criteria:

• Premature newborn baby (< 37 SA) hospitalised in the neonatology department of the NOVO hospital - Pontoise site

• Newborn baby with IUGR (Intra-Uterine Growth Retardation)

• Patient born between 01/01/2012 and 31/12/2023.

• 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.

Related Conditions & MeSH terms

• Premature Birth

Intervention

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)

Locations

Country	Name	City	State
France	Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site	Pontoise

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital NOVO

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Observation of the short-term outcome of neonates discharged from the neonatology department hospital (Pontoise site) between 2012 and 2023 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 31/05/2023. This data will be obtained from the questionnaire sent to the child's parents (question number 9 - "At the time of discharge" section).	At the end of the study, an average of 11 month
Secondary	Observation of weight growth	Z-score measurement for weight. Measured at systematic visits at 2 months, 4 months and 11 months.	At the end of the study, an average of 11 month
Secondary	Observation of height growth	Z-score measurement for height. Measured at systematic visits at 2 months, 4 months and 11 months.	At the end of the study, an average of 11 month
Secondary	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.	At the end of the study, an average of 11 month
Secondary	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).	At the end of the study, an average of 6 month
Secondary	Observation of the incidence of Sudden Unexplained Infant Death Syndrome (SUIDS)	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.	At the end of the study, an average of 11 month
Secondary	Remote observation of parents' experiences	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).	At the end of the study, an average of 6 month
Secondary	Observation of the support offered to parents	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).	At the end of the study, an average of 6 month
Secondary	Description of medical positions on minimum discharge weight	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).	At the end of the study, an average of 6 month