Respiratory Morbidity of Late-Preterm Vs Intrauterine Growth Retarded Infants at School Age

NCT04849494 | Completed DMC

• 1 other identifier: TUTF-GOKAEK 2013/150.
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief 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, 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.

Conditions

Intrauterine Growth Restriction; Preterm Birth

Keywords

Premature Birth; Late preterm; Fetal Growth Retardation; Asthma; School-age

Outcome Measures

Primary Outcomes (1)

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

  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

  between 5 to 7 years of age

Study Arms (3)

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

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

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

Other: ATS-DLD-78-C and ISAAC questionnaires

Interventions

ATS-DLD-78-C and ISAAC questionnaires OTHER

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

Control/Group 3; Late preterm AGA infants/Group 1; Newborns with Intrauterine growth restriction/Group 2

Eligibility Criteria

• Age: 5 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• The presence of major anomalies,
• Patients who did not come to the school-age assessment
• Rejected the informed consent form

Sponsors & Collaborators

• Marmara University: lead

MeSH Terms

Conditions

Fetal Growth Retardation; Premature Birth; Asthma

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 19, 2021
• Study Start: January 1, 2011
• Primary Completion: December 30, 2013
• Study Completion: March 30, 2014
• Last Updated: April 19, 2021

Record last verified: 2021-04