NCT06706128

Brief Summary

Respiratory problems in neonates are one of the leading causes of neonatal morbidity and mortality in developing countries. These respiratory problems are seen in premature neonates, which mainly include respiratory distress syndrome (RDS), pneumonia, requiring ventilatory assistance or oxygen support

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 26, 2024

Completed
Last Updated

November 26, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

November 23, 2024

Last Update Submit

November 23, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Respiratory Rate

    Detected using monitors (Hunt Leigh Healthcare /United Kingdom).

    Respiratory Rate measured at day (0) at after 2 weeks

Study Arms (2)

Group (A)

ACTIVE COMPARATOR

Consisted of twelve Preterm neonates

Other: reflex rolling technique

Group (B)

ACTIVE COMPARATOR

Consisted of twelve Preterm neonates

Other: lung squeezing technique

Interventions

received reflex rolling technique for 20 min, 5 days a week, for 2 weeks.

Group (A)

lung squeezing technique for 20 min, 5 days a week, for 2 weeks

Group (B)

Eligibility Criteria

Age5 Days - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • \) Preterm neonates with pneumonia. 2) Neonates with 30-37 weeks of gestation admitted to NICU. 3) They were free from any major congenital malformation. 4) They were clinically and thermodynamically stable.

You may not qualify if:

  • \) Treatment with neurotropic drugs. 2) Interventricular hemorrhage. 3) Temperature \>38 4) Respiratory and cardiac congenital anomalies. 5) Seizures. 6) Surgical procedures. 7) Genetic Disorders 8) Any segmental or lobar collapse confirmed on chest x-ray. 9) Major airway interventions including change of endo-tracheal tube, hand ventilation or bronchial lavage in the previous 12 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Delta University for Science and Technology

Gamasa, Dakahelia, 35712, Egypt

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2024

First Posted

November 26, 2024

Study Start

July 1, 2024

Primary Completion

September 1, 2024

Study Completion

September 15, 2024

Last Updated

November 26, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations