NCT05816408

Brief Summary

Globally, the estimated preterm birth rate is estimated at 10.6% of all live births, or about 14.8 million infants per year. Breastfeeding is associated with a reduction of risk for several acute and chronic diseases in women and their infants, and the benefits are especially important for small, sick and preterm infants. Important benefits of breastmilk provision for premature and fragile infants including a reduction of the risk for late-onset sepsis, necrotizing enterocolitis, and ventilator-associated pneumonia. In 2020, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) released The Baby friendly Hospital Initiative (BFHI) for small, sick and preterm newborns. Based on the evidence put forward in this document,this review outlines the main steps that health care professionals and facilities can take to support breastfeeding in vulnerable groups of infants. The objective of this study is to summarize essential steps for healthcare personnel and health care facilities to improve breastfeeding practices in small, sick and preterm infants.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2023

Status
unknown

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

First Submitted

Initial submission to the registry

March 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

10 months

First QC Date

March 17, 2023

Last Update Submit

April 14, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • Number of critically ill neonates who receiving breast milk and affect on their weight gain

    This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding weight gain.

    Baseline

  • Number of critically ill neonates who receiving breast milk and affect on their reflexes

    This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding reflexes.

    Baseline

  • Number of critically ill neonates who receiving breast milk and affect on their starting of enteral feeding

    This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding start of enteral feeding

    Baseline

  • Number of critically ill neonates who receiving breast milk and affect on their durtation to stay on mechanical ventilation

    This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding the stay on mechanical ventilation.

    Baseline

  • Number of critically ill neonates who receiving breast milk and affect on their duration of hospital stay

    This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding duration of hospital stay.

    Baseline

Eligibility Criteria

AgeUp to 28 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

50 neonates aged (0-28 days)

You may qualify if:

  • Neonates with critical illness as RDS,pneumonias,perinatal asphyxia,enterocolitis,meconium aspiration syndrome,neonatal sepsis diagnosed on the basis of clinical signs and symptoms

You may not qualify if:

  • neonates cannot breastfeed due to GIT anomalies as esophageal atresia, duodenal atreaia ,congenital hypertrophic pyloric stenosis , intestinal obstruction , metabolic diseases ,complex cardic anomalies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Salah El-Din Amry, Prof

    Assiut University

    PRINCIPAL INVESTIGATOR
  • Amira Mohamed, Assist prof

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 17, 2023

First Posted

April 18, 2023

Study Start

June 1, 2023

Primary Completion

April 1, 2024

Study Completion

September 1, 2024

Last Updated

April 18, 2023

Record last verified: 2023-04