PrematureNCT05301309
Integrative Early Breastfeeding Support in NICU
A study testing breastfeeding consultation in people with Premature, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Background and Purpose: Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Premature
- What is being tested?
- breastfeeding consultation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Mar 2022to 31 Dec 2022
- Phase
- Interventional
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the mother of preterm baby whose gestational age is between 28 weeks and 34 6/7 weeks.
Who cannot join
- mother less than 20-years-old
- not intend to breastfeed
- baby's vital sign is not stable the need frequent medical intervention
- baby had congenital anomaly, gene anomaly, neurological disease, mitochondrial disease or metabolic diseases
- mother or baby receive major surgery
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Pei-Yu Yang, MSc, +886-963566780, ptpeiyuyang@gmail.com
About this study
Official title: The Effects of Integrative Early Breastfeeding Support and Intervention Program on Preterm Infants' Breastfeeding Rate and Neurobehavioral Development and Maternal Mental Health
Background and Purpose: Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. The purpose of this study is to investigate the effect of integrative early breastfeeding support and intervention programs on preterm infants' breastfeeding rate, neurobehavioral development, and maternal mental health. Method: The prospective, single-blinded randomized controlled trial would be conducted in National Taiwan University Children's Hospital in Taipei, Taiwan. We would recruit the mother and infant dyad whose gestational age is between 28 weeks and 34 6/7 weeks. The intervention group (n=22) would receive integrative early breastfeeding support and intervention programs, including breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. The control group (n=22) only receive breastfeeding for prematurity brochure and routine care. Outcome measure: the growth date and types of feeding data at birth, discharge from hospital, 3- and 6-month-old of corrected age would be collected by medical chart review or by interview. Maternal health condition would evaluate by 3 questionnaires, including Breastfeeding Self-Efficacy Scale, Beck Depression Inventory-II and Maternal Confidence Questionnaire. Neurobehavioral development would be measured using Neonatal Neurobehavioral Evaluation-Chinese version and Bayley Scales of infant and toddler development 3rd edition at corrected age of 3-month-old and 6-month-old separately. Demographic data, birth history, types of breastfeeding data would be compared with independent t test or χ2 test. The effect of integrative early breastfeeding support and intervention on growth of preterm infants, neurobehavioral development, types of feeding, and maternal health would be conducted by logistic regression analysis.
Read the detailed description
Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. The purpose of this study is to investigate the effect of integrative early breastfeeding support and intervention programs on preterm infants' breastfeeding rate, neurobehavioral development, and maternal mental health. Method: The prospective, single-blinded randomized controlled trial would be conducted in National Taiwan University Children's Hospital in Taipei, Taiwan. We would recruit the mother and infant dyad whose gestational age is between 28 weeks and 34 6/7 weeks. The intervention group (n=22) would receive integrative early breastfeeding support and intervention programs, including breastfeeding for premature brochure, group education class, weekly interview, one-by-one breastfeeding consultation (at least once during admission) and online peer group support. The control group (n=22) only receive breastfeeding for premature brochure and routine care. Outcome measure: the growth data (including height, weight and head circumference) and types of feeding data at birth, discharge from hospital, 3- and 6-month-old of corrected age would be collected by medical chart review or by interview. Maternal health condition would evaluate by 3 questionnaires, including Breastfeeding Self-Efficacy Scale, Beck Depression Inventory-II and Maternal Confidence Questionnaire. Neuro-behavioral development would be measured using Neonatal Neurobehavioral Evaluation-Chinese version and Bayley Scales of infant and toddler development 3rd edition at corrected age of 3-month-old and 6-month-old separately. Demographic data, birth history, types of breastfeeding data would be compared with independent t test or χ2 test. The effect of integrative early breastfeeding support and intervention on growth of preterm infants, neurobehavioral development, types of feeding, and maternal health would be conducted by logistic regression analysis.
- Conditions
- Premature
- Being tested
- breastfeeding consultation
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
breastfeeding consultationBehavioural
Integrative early breastfeeding support and intervention programs: breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding Consultation | Experimental | The intervention group would receive integrative early breastfeeding support and intervention programs, including "breastfeeding for prematurity brochure", group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. Receives: Behavioral: breastfeeding consultation |
| routine care | Active comparator | The control group only receive "breastfeeding for prematurity brochure" and routine care. Receives: Behavioral: breastfeeding consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral development
Neurobehavioral development was evaluated by Bayley-III
Measured: corrected age 3-month-old
Neurobehavioral development
Neurobehavioral development was evaluated by Bayley-III
Measured: corrected age 6-month-old
Secondary outcomes (15)
body height
baby's body height in centimetres
Measured: corrected age of 3-month-old
body height
baby's body height in centimetres
Measured: corrected age of 6-month-old
body weight
baby's body weight in grams
Measured: corrected age of 3-month-old
body weight
baby's body weight in grams
Measured: corrected age of 6-month-old
head circumference
baby's head circumference in centimetres
Measured: corrected age of 3-month-old
head circumference
baby's head circumference in centimetres
Measured: corrected age of 6-month-old
Breastfeeding Self-Efficacy Scale
Score of "Breastfeeding Self-Efficacy Scale", which minimum score is 14 and maximum score is 70. Higher scores mean better outcome.
Measured: at birth
Breastfeeding Self-Efficacy Scale
Score of "Breastfeeding Self-Efficacy Scale", which minimum score is 14 and maximum score is 70. Higher scores mean better outcome.
Measured: corrected age of 3-month-old
Breastfeeding Self-Efficacy Scale
Score of "Breastfeeding Self-Efficacy Scale", which minimum score is 14 and maximum score is 70. Higher scores mean better outcome.
Measured: corrected age of 6-month-old
Beck Depression Inventory-II
Total score of "Beck Depression Inventory-II". The highest possible total for the test would be 63, and the lowest total of the test would be 0. Higher scores mean worse outcome.
Measured: at birth
Beck Depression Inventory-II
Total score of "Beck Depression Inventory-II". The highest possible total for the test would be 63, and the lowest total of the test would be 0. Higher scores mean worse outcome.
Measured: corrected age of 3-month-old
Beck Depression Inventory-II
Total score of "Beck Depression Inventory-II". The highest possible total for the test would be 63, and the lowest total of the test would be 0. Higher scores mean worse outcome.
Measured: corrected age of 6-month-old
Maternal Confidence Questionnaire
Total score of "Maternal Confidence Questionnaire". The highest possible total for the test would be 70, and the lowest total of the test would be 14. Higher scores mean better outcome.
Measured: at birth
Maternal Confidence Questionnaire
Total score of "Maternal Confidence Questionnaire". The highest possible total for the test would be 70, and the lowest total of the test would be 14. Higher scores mean better outcome.
Measured: corrected age of 3-month-old
Maternal Confidence Questionnaire
Total score of "Maternal Confidence Questionnaire". The highest possible total for the test would be 70, and the lowest total of the test would be 14. Higher scores mean better outcome.
Measured: corrected age of 6-month-old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start16 Mar 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pei-Yu Yang, MSc, Study director, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301309
- Sponsor's protocol ID
- 202106048RIND
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Integrative Early Breastfeeding Support and Intervention Program on Preterm Infants' Breastfeeding Rate and Neurobehavioral Development and Maternal Mental Health
- ClinicalTrials.gov ID
- NCT05301309
- Acronym / sponsor ID
- 202106048RIND
- Conditions
- Premature
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Mar 2022 (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.
Background and Purpose: Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. The purpose of this study is to investigate the effect of integrative early breastfeeding support and intervention programs on preterm infants' breastfeeding rate, neurobehavioral development, and maternal mental health. Method: The prospective, single-blinded randomized controlled trial would be conducted in National Taiwan University Children's Hospital in Taipei, Taiwan. We would recruit the mother and infant dyad whose gestational age is between 28 weeks and 34 6/7 weeks. The intervention group (n=22) would receive integrative early breastfeeding support and intervention programs, including breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. The control group (n=22) only receive breastfeeding for prematurity brochure and routine care. Outcome measure: the growth date and types of feeding data at birth, discharge from hospital, 3- and 6-month-old of corrected age would be collected by medical chart review or by interview. Maternal health condition would evaluate by 3 questionnaires, including Breastfeeding Self-Efficacy Scale, Beck Depression Inventory-II and Maternal Confidence Questionnaire. Neurobehavioral development would be measured using Neonatal Neurobehavioral Evaluation-Chinese version and Bayley Scales of infant and toddler development 3rd edition at corrected age of 3-month-old and 6-month-old separately. Demographic data, birth history, types of breastfeeding data would be compared with independent t test or χ2 test. The effect of integrative early breastfeeding support and intervention on growth of preterm infants, neurobehavioral development, types of feeding, and maternal health would be conducted by logistic regression analysis.
Detailed description
Preterm infants are suffered from preterm-related medical sequelae and neurobehavioral problems, which required interdisciplinary intervention. Breast milk is the best nutrition for preterm infants. However, consistent breastfeeding is quite challenging to most mothers of prematurity. The purpose of this study is to investigate the effect of integrative early breastfeeding support and intervention programs on preterm infants' breastfeeding rate, neurobehavioral development, and maternal mental health. Method: The prospective, single-blinded randomized controlled trial would be conducted in National Taiwan University Children's Hospital in Taipei, Taiwan. We would recruit the mother and infant dyad whose gestational age is between 28 weeks and 34 6/7 weeks. The intervention group (n=22) would receive integrative early breastfeeding support and intervention programs, including breastfeeding for premature brochure, group education class, weekly interview, one-by-one breastfeeding consultation (at least once during admission) and online peer group support. The control group (n=22) only receive breastfeeding for premature brochure and routine care. Outcome measure: the growth data (including height, weight and head circumference) and types of feeding data at birth, discharge from hospital, 3- and 6-month-old of corrected age would be collected by medical chart review or by interview. Maternal health condition would evaluate by 3 questionnaires, including Breastfeeding Self-Efficacy Scale, Beck Depression Inventory-II and Maternal Confidence Questionnaire. Neuro-behavioral development would be measured using Neonatal Neurobehavioral Evaluation-Chinese version and Bayley Scales of infant and toddler development 3rd edition at corrected age of 3-month-old and 6-month-old separately. Demographic data, birth history, types of breastfeeding data would be compared with independent t test or χ2 test. The effect of integrative early breastfeeding support and intervention on growth of preterm infants, neurobehavioral development, types of feeding, and maternal health would be conducted by logistic regression analysis.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding Consultation | Experimental | Behavioral: breastfeeding consultationThe intervention group would receive integrative early breastfeeding support and intervention programs, including "breastfeeding for prematurity brochure", group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. |
| routine care | Active comparator | Behavioral: breastfeeding consultationThe control group only receive "breastfeeding for prematurity brochure" and routine care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the mother of preterm baby whose gestational age is between 28 weeks and 34 6/7 weeks.
Key exclusion criteria (5 listed)
- mother less than 20-years-old
- not intend to breastfeed
- baby's vital sign is not stable the need frequent medical intervention
- baby had congenital anomaly, gene anomaly, neurological disease, mitochondrial disease or metabolic diseases
- mother or baby receive major surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| breastfeeding consultationIntegrative early breastfeeding support and intervention programs: breastfeeding for prematurity brochure, group education class, weekly interview, one-by-one breastfeeding consultation and online peer group support. | Behavioural | Breastfeeding Consultation, routine care |
Primary outcome
Neurobehavioral development
Time frame: corrected age 3-month-old
Neurobehavioral development was evaluated by Bayley-III
Neurobehavioral development
Time frame: corrected age 6-month-old
Neurobehavioral development was evaluated by Bayley-III
15 secondary outcomes
body height
Time frame: corrected age of 3-month-old
body height
Time frame: corrected age of 6-month-old
body weight
Time frame: corrected age of 3-month-old
body weight
Time frame: corrected age of 6-month-old
head circumference
Time frame: corrected age of 3-month-old
head circumference
Time frame: corrected age of 6-month-old
Breastfeeding Self-Efficacy Scale
Time frame: at birth
Breastfeeding Self-Efficacy Scale
Time frame: corrected age of 3-month-old
Breastfeeding Self-Efficacy Scale
Time frame: corrected age of 6-month-old
Beck Depression Inventory-II
Time frame: at birth
Beck Depression Inventory-II
Time frame: corrected age of 3-month-old
Beck Depression Inventory-II
Time frame: corrected age of 6-month-old
Maternal Confidence Questionnaire
Time frame: at birth
Maternal Confidence Questionnaire
Time frame: corrected age of 3-month-old
Maternal Confidence Questionnaire
Time frame: corrected age of 6-month-old
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Premature
RecruitingObservational study
An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Preterm Babies With Retinopathy of Prematurity in the United Kingdom (UK)
Retinopathy of Prematurity, Preterm Infants
Recruiting
REspiratory MEchanics for Delivering Individualised Exogenous Surfactant
Respiratory Distress Syndrome in Premature Infant
Not yet recruitingObservational study
The Effects of Extreme Prematurity on Parenting
Depression Disorder, Post Traumatic Stress Disorder PTSD
Not yet recruitingObservational study
Early Nutrition and Heart Structure and Function in Preterm Infants During the First Year of Life
Cardiac Abnormalities, Nutrient Intake
RecruitingObservational study
Physical Impairments in Premature Ventricular Complex
Premature Ventricular Complexes
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.
Pei-Yu Yang, MSc study director
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing breastfeeding consultation in people with Premature, run by National Taiwan University Hospital at 1 site in Taiwan.
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 5 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Pei-Yu Yang, MSc (+886-2-23123456 ext. 66515, ptpeiyuyang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral development (time frame: corrected age 3-month-old). The study lists 2 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 29 Mar 2022.