Mother-Child RelationshipNCT04142099
Skin-to-Skin Contact Start Time in Newborns Sucking and Mother's Breastfeeding Willingness and Parent-Infant Attachment Associated
A study testing skin to skin contact 60 min group and skin to skin contact 20min group in people with Mother-Child Relationship, run by National Taiwan University Hospital Hsin-Chu Branch at 2 sites in Taiwan.
Trial summary
The maternal and child skin contact in the early postpartum period, so that the newborn can show effective sucking ability, will affect the self-confidence of the mother's feeding, and is also one of the factors affecting the mother's exclusive breastfeeding. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mother-Child Relationship
- What is being tested?
- skin to skin contact 60 min group and skin to skin contact 20min group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 2 sitesTaiwan
- Study dates
- 1 Jan 2019to 1 Nov 2019
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 37 weeks to 40 weeks of gestation
- No high risk pregnancy
- No nipple abnormality
- Willing to breastfeed
- Newborn weight 2500-4000 grams
Who cannot join
- High risk pregnancy
- 37 weeks ago
- Major bleeding during production
- Neonatal life signs abnormality
- Neonatal oral structure abnormalities
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital, Hsin-Chu Branch
Hsinchu, 300
National Taiwan University Hospital Hsinchu Branch
Hsinchu
About this study
The maternal and child skin contact in the early postpartum period, so that the newborn can show effective sucking ability, will affect the self-confidence of the mother's feeding, and is also one of the factors affecting the mother's exclusive breastfeeding. The purpose of this study was to discuss the relationship between the onset of maternal and child skin contact and the relationship between neonatal milk, mother's willingness to breastfeed and parent-child attachment.
Read the detailed description
To study the design of the mining experiment, the healthy full-term newborn and mother who gave birth by vaginal production in the delivery room of a teaching hospital in a northern region, and the maternal skin joints in the birth of the newborn, calculate the time to start execution, and According to the Infant Breastfeeding Assessment Tool (IBFAT), the time spent on spontaneous sucking behavior of newborns is estimated. The sample is estimated to take 20% sample loss rate. The number of cases received is 52 pairs. For 104 pairs, the researchers first filled 52 pairs of the control group and then received 52 pairs of the experimental group. The control group maintained routine treatment. The experimental group immediately contacted the mother and baby skin within 5 minutes of the birth of the newborn. The maternal and child skin contact process was carried out without forced or non-intervention, 48-72 hours after delivery.
The questionnaire was used to evaluate the mother's breastfeeding self-efficacy, breastfeeding social support, and maternal and child dependence relationships to estimate the difference. The results of the study will be based on the Generalized Estimating Equation (GEE) method to analyze the starting time of different groups of postpartum maternal and child skin contact, different time points for neonatal sucking ability, breastfeeding self-efficacy, breastfeeding social support, maternal and child Dependency changes.
On May 23, 2018, the researcher entered and left with the unit nursing director's promotion and consent, from June 1 to June 11.
In order to avoid interference with the interrogation of the subjects, the control group was first received and the experimental group was received. The control group of the pre-existing study was routine care, and no problems were found. The results of this experimental group showed that after the newborn was born, after 45 minutes of contact with the mother and baby, the milk-seeking reflex could occur and after 5 minutes. As a result of effective sucking, the mother expressed her happiness because of the sucking behavior of the newborn, and was willing to cooperate with the completion of the study to have the reference and basis before the study.
- Conditions
- Mother-Child Relationship
- Being tested
- skin to skin contact 60 min group, skin to skin contact 20min group
- Keywords
- early maternal and child skin contact, neonatal sucking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin to skin contact 60 min groupBehavioural
Newborns are exposed to maternal and child skin within five minutes of birth for 60 min.
skin to skin contact 20min groupBehavioural
Newborns are exposed to maternal and child skin within five minutes of birth for 20 min.
| Study group | Role | What they receive |
|---|---|---|
| skin to skin contact 60 min group | Experimental | 1. Newborns are exposed to maternal and child skin within five minutes of birth.
2. Observe the time of newborn spent in suctioning the maternal nipple in 60 minutes of skin to skin contact.
3. No intervention or forced neonatal suction. Receives: Behavioral: skin to skin contact 60 min group |
| skin to skin contact 20 min group | Active comparator | 1. Newborns are exposed to maternal and child skin within five minutes of birth.
2. Observe the time of newborn spent in suctioning the maternal nipple in 20 minutes of skin to skin contact.
3. No intervention or forced neonatal suction. Receives: Behavioral: skin to skin contact 20min group |
What is being measured
The primary outcome is the main question the study is designed to answer.
observational skin to skin contact start time in newborns sucking studies
observational skin to skin contact start time in newborns sucking studies
Measured: for 20 minute
Secondary outcomes (1)
observational skin to skin contact start time in newborns sucking studies
observational skin to skin contact start time in newborns sucking studies
Measured: for 60 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Jan 2019
- Primary completion1 Jul 2019
- Study completion1 Nov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mother-Child RelationshipStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Infant Breastfeeding Assessment Tool Maternal Attachment Inventor Breastfeeding Mothers Social Support Scale Breastfeeding self-efficancy scale-short form
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu Branch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRB of NTUH Hsin-Chu Branch, National Taiwan University Hospital Hsin-Chu Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142099
- Sponsor's protocol ID
- 107-061-E
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- 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 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skin-to-Skin Contact Start Time in Newborns Sucking and Mother's Breastfeeding Willingness and Parent-Infant Attachment Associated
- ClinicalTrials.gov ID
- NCT04142099
- Acronym / sponsor ID
- 107-061-E
- Conditions
- Mother-Child Relationship
- Keywords
- early maternal and child skin contact, neonatal sucking
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Taiwan University Hospital Hsin-Chu BranchUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Nov 2019 (estimated)
- First posted
- 29 Oct 2019 (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.
The maternal and child skin contact in the early postpartum period, so that the newborn can show effective sucking ability, will affect the self-confidence of the mother's feeding, and is also one of the factors affecting the mother's exclusive breastfeeding. The purpose of this study was to discuss the relationship between the onset of maternal and child skin contact and the relationship between neonatal milk, mother's willingness to breastfeed and parent-child attachment.
Detailed description
To study the design of the mining experiment, the healthy full-term newborn and mother who gave birth by vaginal production in the delivery room of a teaching hospital in a northern region, and the maternal skin joints in the birth of the newborn, calculate the time to start execution, and According to the Infant Breastfeeding Assessment Tool (IBFAT), the time spent on spontaneous sucking behavior of newborns is estimated. The sample is estimated to take 20% sample loss rate. The number of cases received is 52 pairs. For 104 pairs, the researchers first filled 52 pairs of the control group and then received 52 pairs of the experimental group. The control group maintained routine treatment. The experimental group immediately contacted the mother and baby skin within 5 minutes of the birth of the newborn. The maternal and child skin contact process was carried out without forced or non-intervention, 48-72 hours after delivery.
The questionnaire was used to evaluate the mother's breastfeeding self-efficacy, breastfeeding social support, and maternal and child dependence relationships to estimate the difference. The results of the study will be based on the Generalized Estimating Equation (GEE) method to analyze the starting time of different groups of postpartum maternal and child skin contact, different time points for neonatal sucking ability, breastfeeding self-efficacy, breastfeeding social support, maternal and child Dependency changes.
On May 23, 2018, the researcher entered and left with the unit nursing director's promotion and consent, from June 1 to June 11.
In order to avoid interference with the interrogation of the subjects, the control group was first received and the experimental group was received. The control group of the pre-existing study was routine care, and no problems were found. The results of this experimental group showed that after the newborn was born, after 45 minutes of contact with the mother and baby, the milk-seeking reflex could occur and after 5 minutes. As a result of effective sucking, the mother expressed her happiness because of the sucking behavior of the newborn, and was willing to cooperate with the completion of the study to have the reference and basis before the study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Infant Breastfeeding Assessment Tool Maternal Attachment Inventor Breastfeeding Mothers Social Support Scale Breastfeeding self-efficancy scale-short form
| Arm | Type | Receives |
|---|---|---|
| skin to skin contact 60 min group | Experimental | Behavioral: skin to skin contact 60 min group1. Newborns are exposed to maternal and child skin within five minutes of birth. 2. Observe the time of newborn spent in suctioning the maternal nipple in 60 minutes of skin to skin contact. 3. No intervention or forced neonatal suction. |
| skin to skin contact 20 min group | Active comparator | Behavioral: skin to skin contact 20min group1. Newborns are exposed to maternal and child skin within five minutes of birth. 2. Observe the time of newborn spent in suctioning the maternal nipple in 20 minutes of skin to skin contact. 3. No intervention or forced neonatal suction. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 37 weeks to 40 weeks of gestation
- No high risk pregnancy
- No nipple abnormality
- Willing to breastfeed
- Newborn weight 2500-4000 grams
Key exclusion criteria (5 listed)
- High risk pregnancy
- 37 weeks ago
- Major bleeding during production
- Neonatal life signs abnormality
- Neonatal oral structure abnormalities
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 |
|---|---|---|
| skin to skin contact 60 min groupNewborns are exposed to maternal and child skin within five minutes of birth for 60 min. | Behavioural | skin to skin contact 60 min group |
| skin to skin contact 20min groupNewborns are exposed to maternal and child skin within five minutes of birth for 20 min. | Behavioural | skin to skin contact 20 min group |
Primary outcome
observational skin to skin contact start time in newborns sucking studies
Time frame: for 20 minute
observational skin to skin contact start time in newborns sucking studies
1 secondary outcome
observational skin to skin contact start time in newborns sucking studies
Time frame: for 60 minute
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin to skin contact 60 min group and skin to skin contact 20min group in people with Mother-Child Relationship, run by National Taiwan University Hospital Hsin-Chu Branch at 2 sites 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 5 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 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
observational skin to skin contact start time in newborns sucking studies (time frame: for 20 minute). 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 Oct 2019.