Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05823064
Collaborator
(none)
20
12

Study Details

Study Description

Brief Summary

Aim of the work:

To assess the respiratory morbidities & outcomes in late preterm infants in the neonatal ICU of Assiut university children's Hospital.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In the world, Preterm birth rates continue to rise. Many reasons account for this increase, such as demographic changes, infertility treatments, increases in maternal age, more multiple gestations, increasing obesity rates, and maternal comorbid conditions.

    To evaluate the occurrence and impact of a condition, a precise definition and its related outcomes are necessary. Thus, a general classification for selected gestational age categories has been reported. Preterm birth refers to all deliveries < 37-0/7 weeks; this classification includes very preterm (< 32-0/7 weeks), moderately preterm (32-0/7 to 33-6/7 weeks), and late preterm births (34-0/7 to 36-6/7 weeks). Term births refer to deliveries that occur from 37-0/7 to 42-0/7 weeks, and post-term births refer to any delivery occurring after 42-0/7 weeks.

    Neonates born between 34 and 36 weeks of gestation (late preterm or near-term births) comprise 71% of all preterm births in the United States.

    Late preterm neonates have significantly higher rates of morbidity and mortality relative to those born at term (37-42 weeks).

    In addition to higher risks for serious health complications, the mortality rate for late preterm infants is 3-fold higher than that for term infants (7.7 vs 2.5 per 1000 live births).

    Late preterm delivery (71% of all preterm births) increases the incidence of respiratory pathology as respiratory distress syndrome (RDS), Transient tachypnea of the newborn (TTN), pneumonia with chest x-ray verification, persistent apnea and bradycardia, pulmonary hypertension, pneumothorax, meconium aspiration, pulmonary hypoplasia,( respiratory failure ) and the need of ventilator support when compared to term delivery.

    Late preterm newborns increase other risks for feeding difficulty, jaundice, hypoglycemia, temperature instability, apnea, and respiratory distress.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU of Assiut University Children Hospital, One Year Study
    Anticipated Study Start Date :
    Jul 1, 2023
    Anticipated Primary Completion Date :
    Jan 1, 2024
    Anticipated Study Completion Date :
    Jul 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. To assess the respiratory morbidities [base line]

      To assess the respiratory morbidities in late preterm infants in neonatal ICU of Assiut university children hospital .

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Day to 28 Days
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • late preterm neonates admitted to the Neonatal intensive care unit (NICU) at Assiut University Children's Hospital for one year.
    Exclusion Criteria:

    patients with congenital heart diseases and multiple congenital anomalies.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Principal Investigator: Nafisa H Refaat, Assiut University
    • Principal Investigator: Mohamed A Sayed, Assiut University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alaa Nady Sadik, principal investigator, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05823064
    Other Study ID Numbers:
    • Respiratory morbidities
    First Posted:
    Apr 21, 2023
    Last Update Posted:
    Apr 21, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided

    Study Results

    No Results Posted as of Apr 21, 2023