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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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).

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 groups in NCT04849494
Study groupRoleWhat they receive
Late preterm AGA infants/Group 1According 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 2Term 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 3the 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.

  1. to evaluate respiratory morbidity of late preterm and IUGR newborns at school age

    Measured: between 5 to 7 years of age

Secondary outcomes (1)
  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.

  1. First posted19 Apr 2021
  2. Study start1 Jan 2011
  3. Primary completion30 Dec 2013
  4. Study completion30 Mar 2014

Resources

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)
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.

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.

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