Intrauterine Growth RestrictionNCT04849494
Respiratory Morbidity of Late-Preterm Vs Intrauterine Growth Retarded Infants at School Age
An observational study of Intrauterine Growth Restriction and Preterm Birth, run by Marmara University.
Trial summary
Background: It is increasingly recognized that late preterm infants have increased respiratory morbidity in the neonatal period as well as decreased lung function in later life. Also, in-utero growth retardation (IUGR) and low birth weight are associated with increased respiratory morbidity beginning from infancy… Read more about this study
- Who is it for?
- Ages 5 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Intrauterine Growth Restriction, Preterm Birth
- What is being tested?
- ATS-DLD-78-C and ISAAC questionnaires
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2011to 30 Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A total number of 160 children were included in the study. Children who admitted to the Neonatal intensive care unit and/or those who were born at the obstetrics unit and followed up with their mothers between January 2006 - December 2008 and reevaluated at school age (5-7 years old) during the study, were divided into two main groups: Late preterm AGA infants: according to the new BALLARD scoring system gestational age was 34-36 6/7 and those who were at the 10-90th percentile according to the Fenton growth curves. Newborns with IUGR: term or preterm infants below 10th percentile according to the values calculated according to Fenton growth curves. And, the healthy term (gestation week 38-42 weeks), AGA newborns, who born between January 2006 and December 2008, were included in the study as a control group
Who may be able to join
- Children who admitted to the Neonatal intensive care unit and/or those who were born at the obstetrics unit and followed up with their mothers between January 2006 - December 2008 and reevaluated at school age (5-7 years old) during the study.
- None of major anomalies,
- Patients who come to the school-age assessment
- Accept the informed consent form
Who cannot join
- The presence of major anomalies,
- Patients who did not come to the school-age assessment
- Rejected the informed consent form
About this study
Background: It is increasingly recognized that late preterm infants have increased respiratory morbidity in the neonatal period as well as decreased lung function in later life. Also, in-utero growth retardation (IUGR) and low birth weight are associated with increased respiratory morbidity beginning from infancy, throughout childhood and into adulthood. However, very few studies have assessed long term respiratory consequences of late preterm birth in comparison with IUGR.
Aim: To determine respiratory morbidity of late-preterm vs infants with IUGR at school age Study Design: Participants included late-preterm AGA infants (34-36, 6/7 weeks), IUGR infants (term/preterm) and term AGA infants born between 2004 and 2008 were included in this study and assessed for respiratory morbidity at school age. To assess the impact of late-preterm birth compared with IUGR and term gestation on respiratory morbidity by using a validated questionnaire. Wheezing, infectious respiratory morbidity and physician-diagnosed asthma panels were evaluated.
Read the detailed description
Our study is a cross-sectional study in which the school-age respiratory morbidity of newborns with late preterm and IUGR birth history who were followed and treated by Trakya University Faculty of Medicine, Department of Pediatrics, Division of Neonatology between January 2006 and December 2008 were evaluated.
A total number of 160 children were included in the study. Children who admitted to the Neonatal intensive care unit and/or those who were born at the obstetrics unit and followed up with their mothers between January 2006 - December 2008 and reevaluated at school age (5-7 years old) during the study, were divided into two main groups: Late preterm AGA infants: according to the new BALLARD scoring system (5) gestational age was 34-36 6/7 and those who were at the 10-90th percentile according to the Fenton growth curves (6) (Group 1). Newborns with IUGR: term or preterm infants below 10th percentile according to the values calculated according to Fenton growth curves (6) (Group 2). In addition to these groups, preterm IUGR infants (<32 weeks of gestation) (Group 2a), and an equal number of preterm AGA infants (<32 weeks of gestation) (Group 3), late preterm (between 34-36 6/7 gestational weeks) IUGR infants (Group 2b) were divided into subgroups. And, the healthy term (gestation week 38-42 weeks), AGA newborns, who born between January 2006 and December 2008, were included in the study as a control group (Group 4) (Figure 1). The presence of major anomalies, patients who did not come to the school-age assessment or and rejected the informed consent form were excluded from the study.
Early (perinatal-neonatal), natal and postnatal period data were recorded from the hospital database system and patient file. The morbidities observed during the follow-up of the newborns, the duration of hospitalization, needed of oxygen, surfactant administration, positive pressure ventilation requirement, and need for mechanical ventilation support and duration were noted from patient file records. During the study, the study and control group cases who were at school age and had perinatal parameters as defined above were contacted by phone and invited to the outpatient clinic. Anthropometric measurements of all patients were taken (Tartımsan brand, TBS model, scale with serial number 1212430 and height meter). Demographic information, socioeconomic level, mother/father education level, mother's smoking status and medical history were questioned, and physical examinations of the patients were performed. The validated Turkish forms of ATS-DLD-78-C (7) and ISAAC questionnaires (8) were tested on 10 randomly selected patients by 2 different investigators to evaluate their intelligibility for screening respiratory diseases. The questionnaires were applied separately to both mother and father and after comparing the answers, it was decided that the questions were understandable. After the physical examination, the questionnaire forms were filled in face-to-face by the research doctor who did not know the patients' medical history (M.C.U).
Responses to the survey questions include; the presence of wheezing/wheezing in the chest independent of having a cold, presence of wheezing in the chest day/night, presence of two or more wheezing episodes causing shortness of breath, the need of using medication during wheezing attacks causing shortness of breath, one or more of the presence of wheezing episodes after exercise or playing games "Respiratory morbidity 1 included wheezing panel", presence of hospitalization due to severe respiratory infection under 2 years of age, having had more than 1 previous bronchiolitis/bronchitis/pneumonia or two or three of them, more than 3 days in the last 3 years of chest disease, cough/sputum attacks lasting at least for a week or longer, sputum, breast fullness, cough present for more than 3 months of the year "Respiratory morbidity 2 included previous infectious respiratory morbidity panel", presence of physician -diagnosed asthma history, current asthma, and the presence of a history of being followed up with a diagnosis of asthma "Respiratory morbidity 3 physician -diagnosed asthma panel" (9-13).
- Conditions
- Intrauterine Growth Restriction, Preterm Birth
- Being tested
- ATS-DLD-78-C and ISAAC questionnaires
- Keywords
- Premature Birth, Late preterm, Fetal Growth Retardation, Asthma, School-age
- Medical subject headings
- Fetal Growth Retardation, Premature Birth, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATS-DLD-78-C and ISAAC questionnairesOther
Early, natal and postnatal period data were recorded from the hospital database system and patient file. The morbidities observed during the follow-up of the newborns, the duration of hospitalization, needed of oxygen, surfactant administration, positive pressure ventilation requirement, and need for mechanical ventilation support and duration were noted from patient file records. Anthropometric measurements of all patients were taken. Demographic information, socioeconomic level, mother/father education level, mother's smoking status and medical history were questioned, and physical examinations of the patients were performed. were performed for screening respiratory diseases. After the physical examination, the validated Turkish forms of ATS-DLD-78-C and ISAAC questionnaires were filled in face-to-face by the research doctor who did not know the patients' medical history
| Study group | Role | What they receive |
|---|---|---|
| Late preterm AGA infants/Group 1 | According to the new BALLARD scoring system gestational age was 34-36 6/7 and those who were at the 10-90th percentile according to the Fenton growth curves Receives: Other: ATS-DLD-78-C and ISAAC questionnaires | |
| Newborns with Intrauterine growth restriction/Group 2 | Term or preterm infants below 10th percentile according to the values calculated according to Fenton growth curves Receives: Other: ATS-DLD-78-C and ISAAC questionnaires | |
| Control/Group 3 | the healthy term (gestation week 38-42 weeks), AGA newborns, who born between January 2006 and December 2008 Receives: Other: ATS-DLD-78-C and ISAAC questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate respiratory morbidity of late preterm and IUGR newborns at school age
Measured: between 5 to 7 years of age
Secondary outcomes (1)
to point out the effects of risk factors encountered in the neonatal period for respiratory morbidity at school age
Measured: between 5 to 7 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start1 Jan 2011
- Primary completion30 Dec 2013
- Study completion30 Mar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrauterine Growth RestrictionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04849494
- Sponsor's protocol ID
- TUTF-GOKAEK 2013/150.
- Status last verified
- Apr 2021
- First submitted
- 13 Apr 2021
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there is an acceptable reason, Individual participant data (IPD) may be made available to other researchers, with the consent of patients.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Morbidity of Late-Preterm Vs Intrauterine Growth Retarded Infants at School Age
- ClinicalTrials.gov ID
- NCT04849494
- Acronym / sponsor ID
- TUTF-GOKAEK 2013/150.
- Conditions
- Intrauterine Growth Restriction, Preterm Birth
- Keywords
- Premature Birth, Late preterm, Fetal Growth Retardation, Asthma, School-age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Dec 2013 (actual)
- Study completion
- 30 Mar 2014 (actual)
- First posted
- 19 Apr 2021 (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.
Background: It is increasingly recognized that late preterm infants have increased respiratory morbidity in the neonatal period as well as decreased lung function in later life. Also, in-utero growth retardation (IUGR) and low birth weight are associated with increased respiratory morbidity beginning from infancy, throughout childhood and into adulthood. However, very few studies have assessed long term respiratory consequences of late preterm birth in comparison with IUGR.
Aim: To determine respiratory morbidity of late-preterm vs infants with IUGR at school age Study Design: Participants included late-preterm AGA infants (34-36, 6/7 weeks), IUGR infants (term/preterm) and term AGA infants born between 2004 and 2008 were included in this study and assessed for respiratory morbidity at school age. To assess the impact of late-preterm birth compared with IUGR and term gestation on respiratory morbidity by using a validated questionnaire. Wheezing, infectious respiratory morbidity and physician-diagnosed asthma panels were evaluated.
Detailed description
Our study is a cross-sectional study in which the school-age respiratory morbidity of newborns with late preterm and IUGR birth history who were followed and treated by Trakya University Faculty of Medicine, Department of Pediatrics, Division of Neonatology between January 2006 and December 2008 were evaluated.
A total number of 160 children were included in the study. Children who admitted to the Neonatal intensive care unit and/or those who were born at the obstetrics unit and followed up with their mothers between January 2006 - December 2008 and reevaluated at school age (5-7 years old) during the study, were divided into two main groups: Late preterm AGA infants: according to the new BALLARD scoring system (5) gestational age was 34-36 6/7 and those who were at the 10-90th percentile according to the Fenton growth curves (6) (Group 1). Newborns with IUGR: term or preterm infants below 10th percentile according to the values calculated according to Fenton growth curves (6) (Group 2). In addition to these groups, preterm IUGR infants (<32 weeks of gestation) (Group 2a), and an equal number of preterm AGA infants (<32 weeks of gestation) (Group 3), late preterm (between 34-36 6/7 gestational weeks) IUGR infants (Group 2b) were divided into subgroups. And, the healthy term (gestation week 38-42 weeks), AGA newborns, who born between January 2006 and December 2008, were included in the study as a control group (Group 4) (Figure 1). The presence of major anomalies, patients who did not come to the school-age assessment or and rejected the informed consent form were excluded from the study.
Early (perinatal-neonatal), natal and postnatal period data were recorded from the hospital database system and patient file. The morbidities observed during the follow-up of the newborns, the duration of hospitalization, needed of oxygen, surfactant administration, positive pressure ventilation requirement, and need for mechanical ventilation support and duration were noted from patient file records. During the study, the study and control group cases who were at school age and had perinatal parameters as defined above were contacted by phone and invited to the outpatient clinic. Anthropometric measurements of all patients were taken (Tartımsan brand, TBS model, scale with serial number 1212430 and height meter). Demographic information, socioeconomic level, mother/father education level, mother's smoking status and medical history were questioned, and physical examinations of the patients were performed. The validated Turkish forms of ATS-DLD-78-C (7) and ISAAC questionnaires (8) were tested on 10 randomly selected patients by 2 different investigators to evaluate their intelligibility for screening respiratory diseases. The questionnaires were applied separately to both mother and father and after comparing the answers, it was decided that the questions were understandable. After the physical examination, the questionnaire forms were filled in face-to-face by the research doctor who did not know the patients' medical history (M.C.U).
Responses to the survey questions include; the presence of wheezing/wheezing in the chest independent of having a cold, presence of wheezing in the chest day/night, presence of two or more wheezing episodes causing shortness of breath, the need of using medication during wheezing attacks causing shortness of breath, one or more of the presence of wheezing episodes after exercise or playing games "Respiratory morbidity 1 included wheezing panel", presence of hospitalization due to severe respiratory infection under 2 years of age, having had more than 1 previous bronchiolitis/bronchitis/pneumonia or two or three of them, more than 3 days in the last 3 years of chest disease, cough/sputum attacks lasting at least for a week or longer, sputum, breast fullness, cough present for more than 3 months of the year "Respiratory morbidity 2 included previous infectious respiratory morbidity panel", presence of physician -diagnosed asthma history, current asthma, and the presence of a history of being followed up with a diagnosis of asthma "Respiratory morbidity 3 physician -diagnosed asthma panel" (9-13).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Late preterm AGA infants/Group 1 | – | Other: ATS-DLD-78-C and ISAAC questionnairesAccording to the new BALLARD scoring system gestational age was 34-36 6/7 and those who were at the 10-90th percentile according to the Fenton growth curves |
| Newborns with Intrauterine growth restriction/Group 2 | – | Other: ATS-DLD-78-C and ISAAC questionnairesTerm or preterm infants below 10th percentile according to the values calculated according to Fenton growth curves |
| Control/Group 3 | – | Other: ATS-DLD-78-C and ISAAC questionnairesthe healthy term (gestation week 38-42 weeks), AGA newborns, who born between January 2006 and December 2008 |
Who may qualify
- Ages
- 5 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A total number of 160 children were included in the study. Children who admitted to the Neonatal intensive care unit and/or those who were born at the obstetrics unit and followed up with their mothers between January 2006 - December 2008 and reevaluated at school age (5-7 years old) during the study, were divided into two main groups: Late preterm AGA infants: according to the new BALLARD scoring system gestational age was 34-36 6/7 and those who were at the 10-90th percentile according to the Fenton growth curves. Newborns with IUGR: term or preterm infants below 10th percentile according to the values calculated according to Fenton growth curves. And, the healthy term (gestation week 38-42 weeks), AGA newborns, who born between January 2006 and December 2008, were included in the study as a control group
Key inclusion criteria (4 listed)
- Children who admitted to the Neonatal intensive care unit and/or those who were born at the obstetrics unit and followed up with their mothers between January 2006 - December 2008 and reevaluated at school age (5-7 years old) during the study.
- None of major anomalies,
- Patients who come to the school-age assessment
- Accept the informed consent form
Key exclusion criteria (3 listed)
- The presence of major anomalies,
- Patients who did not come to the school-age assessment
- Rejected the informed consent form
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 |
|---|---|---|
| ATS-DLD-78-C and ISAAC questionnairesEarly, natal and postnatal period data were recorded from the hospital database system and patient file. The morbidities observed during the follow-up of the newborns, the duration of hospitalization, needed of oxygen, surfactant administration, positive pressure ventilation requirement, and need for mechanical ventilation support and duration were noted from patient file records. Anthropometric measurements of all patients were taken. Demographic information, socioeconomic level, mother/father education level, mother's smoking status and medical history were questioned, and physical examinations of the patients were performed. were performed for screening respiratory diseases. After the physical examination, the validated Turkish forms of ATS-DLD-78-C and ISAAC questionnaires were filled in face-to-face by the research doctor who did not know the patients' medical history | Other | Control/Group 3, Late preterm AGA infants/Group 1, Newborns with Intrauterine growth restriction/Group 2 |
Primary outcome
to evaluate respiratory morbidity of late preterm and IUGR newborns at school age
Time frame: between 5 to 7 years of age
1 secondary outcome
to point out the effects of risk factors encountered in the neonatal period for respiratory morbidity at school age
Time frame: between 5 to 7 years of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Individual participant dataSharing planned: Undecided. If there is an acceptable reason, Individual participant data (IPD) may be made available to other researchers, with the consent of patients.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intrauterine Growth Restriction and Preterm Birth, run by Marmara University.
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 4 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: finished, as of the sponsor's last update on 19 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate respiratory morbidity of late preterm and IUGR newborns at school age (time frame: between 5 to 7 years of age). 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 19 Apr 2021.