Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU

April 10, 2023 updated by: Alaa Nady Sadik, Assiut University

Respiratory Morbidities and Outcome in Late Preterm in Neonatal ICU of Assiut University Children Hospital, One Year Study

Aim of the work:

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

Study Overview

Status

Not yet recruiting

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 Type

Observational

Enrollment (Anticipated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

20 Neonates born between 34 and 36 weeks of gestation

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the respiratory morbidities
Time Frame: base line
To assess the respiratory morbidities in late preterm infants in neonatal ICU of Assiut university children hospital .
base line

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 1, 2023

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

April 10, 2023

First Submitted That Met QC Criteria

April 10, 2023

First Posted (Actual)

April 21, 2023

Study Record Updates

Last Update Posted (Actual)

April 21, 2023

Last Update Submitted That Met QC Criteria

April 10, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Respiratory morbidities

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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