Premature BirthPetit-PoidsNCT06224764
Assessment of the Impact of the Return Home of Premature Newborns Less Than 2 Kilos Morbidity/Mortality
A study testing Mother and Father questionnaires in people with Premature Birth, run by Hôpital NOVO at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 1 month to 11 years
- Conditions the study is for
- Premature Birth
- What is being tested?
- Mother and Father questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 21 Feb 2024to Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Newborn transferred to another hospital before discharge.
- Refusal by one of the parents.
- Parent does not speak or understand French.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Resuscitation and neonatal medicine department - Hôpital NOVO - Pontoise site
Pontoise, 95300
Dr Suzanne BORRHOMEE, +33 1 30 75 50 32, suzanne.borrhomee@ght-novo.fr
Dr Rayane MAHFOUZ, +33 1 30 75 50 32, rayane.mahfouz@gmail.com
About this study
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
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.
Read the 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.
- Conditions
- Premature Birth
- Being tested
- Mother and Father questionnaires
- Keywords
- Prematurity, Weight at discharge, Morbi-mortality, Neonatology
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mother and Father questionnairesOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Mother and Father questionnaires | Other | 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) Receives: Other: Mother and Father questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At the end of the study, an average of 11 month
Secondary outcomes (8)
Observation of weight growth
Z-score measurement for weight. Measured at systematic visits at 2 months, 4 months and 11 months.
Measured: At the end of the study, an average of 11 month
Observation of height growth
Z-score measurement for height. Measured at systematic visits at 2 months, 4 months and 11 months.
Measured: At the end of the study, an average of 11 month
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.
Measured: At the end of the study, an average of 11 month
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).
Measured: At the end of the study, an average of 6 month
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.
Measured: At the end of the study, an average of 11 month
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).
Measured: At the end of the study, an average of 6 month
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).
Measured: At the end of the study, an average of 6 month
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).
Measured: At the end of the study, an average of 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start21 Feb 2024
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premature BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Mother and Father questionnaires (on paper or by phone).
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hôpital NOVO
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Suzanne BORRHOMEE, Principal investigator, Hôpital NOVO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224764
- Sponsor's protocol ID
- CHRD1722
- Other IDs
- 2023-A02200-45
- Acronym
- Petit-Poids
- Status last verified
- Dec 2024
- First submitted
- 2 Jan 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06224764
- Acronym / sponsor ID
- Petit-Poids / CHRD1722
- Conditions
- Premature Birth
- Keywords
- Prematurity, Weight at discharge, Morbi-mortality, Neonatology
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hôpital NOVOUniversity, hospital or other
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Mother and Father questionnaires (on paper or by phone).
| Arm | Type | Receives |
|---|---|---|
| Mother and Father questionnaires | Other | Other: Mother and Father questionnairesMother and Father questionnaires (on paper or by phone) and data collectionon newborns weighing less than 2 kilos (at discharge from birth to 11 months) |
Who may qualify
- Ages
- 1 month to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Newborn transferred to another hospital before discharge.
- Refusal by one of the parents.
- Parent does not speak or understand French.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mother and Father questionnairesMother and Father questionnaires (on paper or by phone) and data collectionon newborns weighing less than 2 kilos (at discharge from birth to 11 months) | Other | Mother and Father questionnaires |
Primary outcome
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
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).
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Suzanne BORRHOMEE principal investigator
Hôpital NOVO
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mother and Father questionnaires in people with Premature Birth, run by Hôpital NOVO at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maryline DELATTRE (+3333130754131, maryline.delattre@ght-novo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: At the end of the study, an average of 11 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2025.