Parental Anxiety Following Premature BirthPréDANPaNCT05734768
Impact of Preterm Birth on Symptoms of Anxiety and Depression in Parents, and on the Precursors of Cognition, Including Social Cognition in Their Child
An observational study of Parental Anxiety Following Premature Birth, run by CHU de Reims at 1 site in France.
Trial summary
In 2018, the World Health Organization (WHO) counted no less than 15 million preterm births each year worldwide, or more than one in ten children. In recent years, the number of newborns surviving preterm birth has gradually increased due to advances in neonatal medicine. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parental Anxiety Following Premature Birth
- What is being tested?
- State-Trait Anxiety Inventory - Y ou STAI-Y
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Nov 2023to 28 May 2028
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants included will be children born preterm (32 - 37 SA) and their parents, and children born at term and their parents, who meet the inclusion criteria and who have accepted to participate in the study.
Who may be able to join
- Children and their parents will be included in the study in the exposed group if:
- the infant is born preterm, i.e., between 32 weeks of amenorrhea (SA) and 36 SA + 6 days.
- at the maternity ward of the University Hospital of Reims
- the parents are older than 18 years.
- parents are affiliated to a social insurance.
- parents agreed to participate in the study, within 72 hours after birth
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- Will be included in the study, in the non-exposed group, children and their parents, if:
- the children is born at term, i.e., from 37 SA + 0 Days
- at the maternity ward of the Reims University Hospital
- parents are older than 18 years.
- parents are affiliated to a social insurance.
- parents agreed to participate in the study, within 72 hours after birth
Who cannot join
- Will not be included in the study, children and their parents, if:
- the infant is born from multiple pregnancy
- the infant is hemodynamically unstable
- the birth occured more than 72 hours ago
- the infant is affected by congenital malformations
- the infant is affected by severe brain lesion detected by transfontanellar ultrasound scan performed before inclusion (cystic leukomalacia, and stages III and IV of the Papille classification i.e. severe ventricular dilatation or intra-parenchymal hemorrhage)
Show all 12Show fewer
- separation from the parents and placement of the child is intended
- child is born anounymously
- parents with psychiatric disorders
- if the mother is suffering from hemodynamic compromise
- parents under guardianship
- parents non-native speaking
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
Chu Reims
Reims, 51092
Damien JOLLY, 326788472 ext. 33, djolly@chu-reims.fr
About this study
In 2018, the World Health Organization (WHO) counted no less than 15 million preterm births each year worldwide, or more than one in ten children. In recent years, the number of newborns surviving preterm birth has gradually increased due to advances in neonatal medicine. However, these rescues are not without consequences.
Indeed, to do so, the child is separated from his parents, placed in a stressful, technical and potentially painful environment. This early separation is compounded by medical co-morbidities and sedations that compromise the child's physiology and availability to interact. Extreme prematurity also disrupts the early interactions between the child and his parents, and eventually the relationships with others. Thus, more than 35% of children born prematurely show insecure attachment behavior in their relationships with others.
Read more
Moreover, premature births are accompanied by numerous somatic, cognitive and social cognitive difficulties. At school age, these children present more learning, social-emotional and behavioral problems. The greater the degree of prematurity, the more marked these difficulties are. They would be associated with an executive and social cognition deficit, inherent to a globally altered cerebral development, in particular the frontal subcortical cerebral regions.
On the parents' side, premature birth is also fraught with consequences. Indeed, the idea of an idealized post-natal period gives way to an anxious, even traumatic experience. Notions of guilt are often expressed, as well as major anxiety about the child's survival and "parenting skills". A higher prevalence of signs of parental anxiety, postnatal depression and post-traumatic stress disorder is observed in mothers of premature infants, even up to 18 months after birth. These psychological states influence the parents' ability to interact with their newborn, as well as the content of these interactions.
Finally, both parents and newborns see, for different reasons, their ability to interact and to reassure themselves profoundly disrupted by premature birth.
Even if since 2010, prematurity has been identified as a "public health problem" by the WHO, studies on the subject still have limitations. Indeed, if we estimate that the prevalence of anxiety and/or depression signs in mothers of premature babies is on average three times higher than in mothers of full-term babies; what about fathers? It seems fundamental to improve our knowledge of the anxious and depressive symptoms that fathers and mothers of premature babies may display, with the aim of providing comprehensive and multidisciplinary care for families in neonatal intensive care units.
Similarly, the exact impact of an increase in parental anxious depressive symptomatology on the precursors of cognitive and social cognitive development is not known. Since the environment and stimulation are fundamental to the child's development, what happens when one or both parents have their interaction modified by anxious-depressive symptomatology? Indeed, the rare studies publishing data on the subject are carried out on populations of parents of non-premature children, often non-French-speaking and above all with tools that are not available to French-speaking practitioners in charge of the early detection of developmental difficulties in premature children. Today, it seems necessary to provide data concerning the development of precursors to cognitive and social cognitive development in preterm infants, and to better understand the extent of its interaction with the anxious depressive symptomatology of the mother and father.
The investigators therefore formulate the following hypotheses:
- Anxious depressive symptomatology, such as signs of parental anxiety, postnatal depression, and posttraumatic stress disorder, would be higher in mothers and fathers of preterm infants than in mothers and fathers of full-term infants at 7 ± 1 weeks after birth.
- The level of development of the precursors to cognitive and social cognitive development would be lower in children whose parents present an exacerbated anxious depressive symptomatology.
- Being tested
- State-Trait Anxiety Inventory - Y ou STAI-Y
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety Inventory - Y ou STAI-YBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Preterm newborns and their parents | Thirty premature children born between 32 and 36+6 weeks of gestation, and their parents. Receives: Behavioral: State-Trait Anxiety Inventory - Y ou STAI-Y | |
| term newborns and their parents | Thirty children, born at more than 37 weeks (≥37+0), and their parents Receives: Behavioral: State-Trait Anxiety Inventory - Y ou STAI-Y |
What is being measured
The primary outcome is the main question the study is designed to answer.
STAI-Y : State Trait Inventory Anxiety - Y
used to compare level of anxiety and depression in mothers of infants born preterm (32 to 37 gestational age) vs mothers of infants born at term (37 to 41 gestational age)
Measured: week 7 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start28 Nov 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion28 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parental Anxiety Following Premature BirthStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734768
- Sponsor's protocol ID
- PA23021*
- Acronym
- PréDANPa
- Status last verified
- Nov 2025
- First submitted
- 9 Feb 2023
- Last updated
- 2 Dec 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 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Preterm Birth on Symptoms of Anxiety and Depression in Parents, and on the Precursors of Cognition, Including Social Cognition in Their Child
- ClinicalTrials.gov ID
- NCT05734768
- Acronym / sponsor ID
- PréDANPa / PA23021*
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 May 2028 (estimated)
- First posted
- 21 Feb 2023 (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.
In 2018, the World Health Organization (WHO) counted no less than 15 million preterm births each year worldwide, or more than one in ten children. In recent years, the number of newborns surviving preterm birth has gradually increased due to advances in neonatal medicine. However, these rescues are not without consequences.
Indeed, to do so, the child is separated from his parents, placed in a stressful, technical and potentially painful environment. This early separation is compounded by medical co-morbidities and sedations that compromise the child's physiology and availability to interact. Extreme prematurity also disrupts the early interactions between the child and his parents, and eventually the relationships with others. Thus, more than 35% of children born prematurely show insecure attachment behavior in their relationships with others.
Moreover, premature births are accompanied by numerous somatic, cognitive and social cognitive difficulties. At school age, these children present more learning, social-emotional and behavioral problems. The greater the degree of prematurity, the more marked these difficulties are. They would be associated with an executive and social cognition deficit, inherent to a globally altered cerebral development, in particular the frontal subcortical cerebral regions.
On the parents' side, premature birth is also fraught with consequences. Indeed, the idea of an idealized post-natal period gives way to an anxious, even traumatic experience. Notions of guilt are often expressed, as well as major anxiety about the child's survival and "parenting skills". A higher prevalence of signs of parental anxiety, postnatal depression and post-traumatic stress disorder is observed in mothers of premature infants, even up to 18 months after birth. These psychological states influence the parents' ability to interact with their newborn, as well as the content of these interactions.
Finally, both parents and newborns see, for different reasons, their ability to interact and to reassure themselves profoundly disrupted by premature birth.
Even if since 2010, prematurity has been identified as a "public health problem" by the WHO, studies on the subject still have limitations. Indeed, if we estimate that the prevalence of anxiety and/or depression signs in mothers of premature babies is on average three times higher than in mothers of full-term babies; what about fathers? It seems fundamental to improve our knowledge of the anxious and depressive symptoms that fathers and mothers of premature babies may display, with the aim of providing comprehensive and multidisciplinary care for families in neonatal intensive care units.
Similarly, the exact impact of an increase in parental anxious depressive symptomatology on the precursors of cognitive and social cognitive development is not known. Since the environment and stimulation are fundamental to the child's development, what happens when one or both parents have their interaction modified by anxious-depressive symptomatology? Indeed, the rare studies publishing data on the subject are carried out on populations of parents of non-premature children, often non-French-speaking and above all with tools that are not available to French-speaking practitioners in charge of the early detection of developmental difficulties in premature children. Today, it seems necessary to provide data concerning the development of precursors to cognitive and social cognitive development in preterm infants, and to better understand the extent of its interaction with the anxious depressive symptomatology of the mother and father.
The investigators therefore formulate the following hypotheses:
- Anxious depressive symptomatology, such as signs of parental anxiety, postnatal depression, and posttraumatic stress disorder, would be higher in mothers and fathers of preterm infants than in mothers and fathers of full-term infants at 7 ± 1 weeks after birth.
- The level of development of the precursors to cognitive and social cognitive development would be lower in children whose parents present an exacerbated anxious depressive symptomatology.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm newborns and their parents | – | Behavioral: State-Trait Anxiety Inventory - Y ou STAI-YThirty premature children born between 32 and 36+6 weeks of gestation, and their parents. |
| term newborns and their parents | – | Behavioral: State-Trait Anxiety Inventory - Y ou STAI-YThirty children, born at more than 37 weeks (≥37+0), and their parents |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants included will be children born preterm (32 - 37 SA) and their parents, and children born at term and their parents, who meet the inclusion criteria and who have accepted to participate in the study.
Key inclusion criteria (12 listed)
- the infant is born preterm, i.e., between 32 weeks of amenorrhea (SA) and 36 SA + 6 days.
- at the maternity ward of the University Hospital of Reims
- the parents are older than 18 years.
- parents are affiliated to a social insurance.
- parents agreed to participate in the study, within 72 hours after birth
Key exclusion criteria (12 listed)
- the infant is born from multiple pregnancy
- the infant is hemodynamically unstable
- the birth occured more than 72 hours ago
- the infant is affected by congenital malformations
- the infant is affected by severe brain lesion detected by transfontanellar ultrasound scan performed before inclusion (cystic leukomalacia, and stages III and IV of the Papille classification i.e. severe ventricular dilatation or intra-parenchymal hemorrhage)
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 |
|---|---|---|
| State-Trait Anxiety Inventory - Y ou STAI-YQuestionnaire | Behavioural | Preterm newborns and their parents, term newborns and their parents |
Primary outcome
STAI-Y : State Trait Inventory Anxiety - Y
Time frame: week 7 weeks post partum
used to compare level of anxiety and depression in mothers of infants born preterm (32 to 37 gestational age) vs mothers of infants born at term (37 to 41 gestational age)
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 2 Dec 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parental Anxiety Following Premature Birth, run by CHU de Reims 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 12 inclusion and 12 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 2 Dec 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 Julien EUTROPE (3 26 78 94 76 ext. 0033, jeutrope@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
STAI-Y : State Trait Inventory Anxiety - Y (time frame: week 7 weeks post partum). 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 2 Dec 2025.