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Breast FeedingNCT05816408

Effect of Breast Milk Feeding on Critically Ill Neonates

An observational study of Breast Feeding, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages Up to 28 days
Conditions the study is for
Breast Feeding
How many people
50 participants
Where
No sites listed yet
Study dates
1 Jun 2023to 1 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 28 days
  • All sexes
  • Child

Study population: 50 neonates aged (0-28 days)

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Mohamed Mohsen contact

01099229464

m.mohsen.doc@gmail.com

About this study

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.

Read the detailed description

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.

Breastfeeding initiation and skin-to-skin care Providers should support all mothers and infants with immediate skin-to-skin care (SSC) after birth and assist mothers to initiate breastfeeding (or breastmilk expression and feedings) as soon as possible. A systematic review and meta-analysis on very early breastfeeding initiation and neonatal mortality in 136,047 infants found that breastfeeding initiation 2_23 h after birth was associated with a 33% higher risk of mortality compared to breastfeeding initiation _1 h after birth, however potential confounding by factors such as health challenges causing both delayed initiation and increased mortality needs to be considered.

Skin-to-skin care improves breastfeeding rates in very preterm infants. In infants with low-birth weight, evidence from a Cochrane review supports the use of skin to skin care for reduction of both infant mortality and morbidity, especially in low income settings.

Skin-to-skin care helps to stabilize infants' body temperature and blood sugar and helps to reduce infant procedural pain, even in very preterm neonates.It also stabilizes preterm infants' respiratory function, which isthought to be guided by the caregiver's cardiac rhythm. Compared to incubator care, cerebral oxygenation and other physiological parameters in ventilated preterm infants has not been shown to become more unstable during SSC with their mothers.Skin-to-skin contact has positive effects on the neonate's microbiome through population of the neonate's skin with beneficial bacteria and has been shown to decrease the risk of nosocomial infections. Regular and prolonged SSC can reduce the risk of hospital-acquired infections, bronchopulmonary dysplasia and cholestasis in a dose-dependent fashion, even in very preterm infants.

Responsive (on-demand) breastfeeding means following an infant's feeding cues to guide feeding times. If the infant does not have contraindications to enteral feeding, breastfeeding or feeding of expressed human milk can be initiated as soon as the infant has stable vital signs, which most of the time can begin within the first few hours of life.Because preterm infants are neurologically immature, responsive feeding may not be possible initially. However,as preterm infants mature, semi-demand feeding can be started, which means that breastfeeding is initiated in response to infant cues, but ended when the infant stops suckling.

Exclusive breastfeeding rates for premature infants have been shown to drop significantly after discharge. Healthcare teams can support families through connecting them to clinical and community-based referrals after hospital discharge (e.g. paediatricians , lactation consultants, breastfeeding peer support groups). Beyond referrals, healthcare professionals should bear in mind that the hospitalization period for small, sick or preterm neonates may pose challenges to bonding and attachment and parents' confidence as caregivers. Therefore, preparing parents for bringing fragile infants home is essential.Qualitative studies with parents of neonates have demonstrated that parents value dialogue and timely communication with the healthcare team prior to discharge. These studies underline the importance of including support persons (fathers or partners) in conversations and planning for the transition home.Preterm infants exclusively breastfed after discharge are at increased risk of low lean body mass and low bone mineral density, and continued provision of fortifier in addition to breastfeeding after discharge.

Conditions
Breast Feeding
Medical subject headings
Breast Feeding

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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

    Measured: Baseline

  4. 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.

    Measured: Baseline

  5. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2023
  2. Study start1 Jun 2023 (estimated)
  3. Primary completion1 Apr 2024 (estimated)
  4. Study completion1 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05816408
Sponsor's protocol ID
Effect of breast milk feeding
Status last verified
Apr 2023
First submitted
17 Mar 2023
Last updated
18 Apr 2023
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Breast Feeding, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mohamed Mohsen (01099229464, m.mohsen.doc@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of critically ill neonates who receiving breast milk and affect on their weight gain (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 7 Nov 2026.

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