Breast FeedingNCT05816408
Effect of Breast Milk Feeding on Critically Ill Neonates
An observational study of Breast Feeding, run by Assiut University.
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.
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.
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
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
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
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
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.
- First posted18 Apr 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast FeedingStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mohsen Ezzat, Assiut University
- Investigators
- Salah El-Din Amry, Prof, Principal investigator, Assiut UniversityAmira Mohamed, Assist prof, Principal investigator, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Breast Milk Feeding on Critically Ill Neonates
- ClinicalTrials.gov ID
- NCT05816408
- Acronym / sponsor ID
- Effect of breast milk feeding
- Conditions
- Breast Feeding
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Age groups
- Child
- Study population
- 50 neonates aged (0-28 days)
Key inclusion criteria (1 listed)
- Neonates with critical illness as RDS,pneumonias,perinatal asphyxia,enterocolitis,meconium aspiration syndrome,neonatal sepsis diagnosed on the basis of clinical signs and symptoms
Key exclusion criteria (1 listed)
- neonates cannot breastfeed due to GIT anomalies as esophageal atresia, duodenal atreaia ,congenital hypertrophic pyloric stenosis , intestinal obstruction , metabolic diseases ,complex cardic anomalies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of critically ill neonates who receiving breast milk and affect on their weight gain
Time frame: Baseline
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding weight gain.
Number of critically ill neonates who receiving breast milk and affect on their reflexes
Time frame: Baseline
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding reflexes.
Number of critically ill neonates who receiving breast milk and affect on their starting of enteral feeding
Time frame: Baseline
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding start of enteral feeding
Number of critically ill neonates who receiving breast milk and affect on their durtation to stay on mechanical ventilation
Time frame: Baseline
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding the stay on mechanical ventilation.
Number of critically ill neonates who receiving breast milk and affect on their duration of hospital stay
Time frame: Baseline
This study was aimed to assess the effect of breast milk feeding on critically ill neonates regarding duration of hospital stay.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Salah El-Din Amry, Prof principal investigator
Assiut University
Amira Mohamed, Assist prof principal investigator
Assiut University
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.