Breast FeedingCPPITLHNCT02687685
Clinical Trial of Immediate Skin to Skin Contact at Birth Early vs. Immediate (CPPITLH)
A study testing Skin to skin contact immediate and skin to skin contact early in people with Breast Feeding, run by Universidad de la Sabana at 1 site in Colombia.
Trial summary
SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period strategy that has proven to benefit the initiation and continuation of human lactation and decreased hospitalization during the first week… Read more about this study
- Who is it for?
- Ages Up to 60 minutes
- Conditions the study is for
- Breast Feeding
- What is being tested?
- Skin to skin contact immediate and skin to skin contact early
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteColombia
- Study dates
- Sep 2018to Mar 2020
- 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 Up to 60 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants of mothers who express before the birth, their desire to breastfeed their newborn baby.
- Infants born between 7:00 am and 5:00 pm Monday through Friday in the USC.
- Full-term newborns defined by obstetric method and confirmed by paediatric method (Ballard), between 37 and 42 weeks of gestation, with appropriate weight for gestational age (between 10th and 90th percentiles for gestational age).
- Vaginal birth.
- Do not require basic or advanced neonatal resuscitation manoeuvres.
- Healthy and stable cardiorespiratory at birth.
- Have been permitted to room with the mother.
Who cannot join
- Mothers and newborns that present absolute or relative contraindications for human lactation.
- Multiple births and pregnancies.
- Mothers with postpartum complications that limit the onset of human lactation.
- Major congenital malformations that prevent human lactation.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario de la Samaritana Unidad Funcional Zipaquira
Zipaquirá, Cundinamarca, 250251
About this study
Official title: Randomized Clinical Trial of Immediate Skin to Skin Contact (SSC) at Birth, Early vs. Immediate, on the Duration of Exclusive Human Lactation in Full-term Newborns Treated at the Universidad de La Sabana Clinic
SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period strategy that has proven to benefit the initiation and continuation of human lactation and decreased hospitalization during the first week of life. This study aims to determine the effect of the initiation of SSC at birth (immediate vs. early) in healthy, full term newborns treated at Universidad de La Sabana Clinic, on the duration of exclusive human lactation.
Research question: What is the effect of immediate SSC at birth (immediate vs. early) on the duration of exclusive human lactation in full-term newborns treated at the Universidad de La Sabana Clinic?
Read more
Methodology: A random blind clinical trial was performed in which full-term healthy newborns that are attended at the Universidad de La Sabana Clinic are included. The blind participants will be those persons measuring the results and analysing the data. The sample size is calculated for a type I error of 5%, a two tailed type II error of 20%, therefore estimating percentage losses of 30%; 150 infants were included per group. Randomization will be performed using permuted, size 6 blocks. Descriptive analysis will be conducted using central tendency and dispersion measurements. A bivariate analysis will be performed to determine which variables are associated with exclusive human lactation at 6 months. For continuous variables, the Student t- test will be used for independent samples or the Wilcoxon rank sum test, in case the assumptions of normality for the t-tests are not fulfilled. The assumption of normality will be evaluated with the Shapiro Wilk and Kolmogorov-Smirnov test. Categorical variables in contingency tables will be constructed, assessing independence between variables with the Chi-square test or Fisher's exact test when the assumption of the number of cases is not met by the cells in the contingency tables, times two. It will be calculated as a measurement of the effect of relative risk (RR) with confidence intervals; the adjusted measurements will be calculated using a multivaried regression Poisson model, variables with significant results will be used in the bivariate analysis and those with biological plausibility used for the adjustment. The analysis will be carried out for a two-tailed type I error level of 5%. The Stata 11 program will be used for the data analysis. An interim analysis will be performed upon submission of half of the expected events (106), setting limits for early termination of the trial according to the method proposed by Pampallona and Tsiatis (1994).
Intervention: There will be 2 SSC randomization groups, early vs. immediate. After completing the neonatal adaptation process and according to the group assignment, it will proceed to leave the newborn with the mother in accommodation. Prior to discharge, the IBFAT scale will be applied. Monitoring will initially be performed with a face valuation between 3 and 10 days of life, then monthly telephone calls for 6 months to verify the status of human lactation.
Results: To determine whether early versus immediate SSC has an impact on the duration of exclusive human lactation.
- Conditions
- Breast Feeding
- Being tested
- Skin to skin contact immediate, skin to skin contact early
- Keywords
- Skin to Skin Contact, Infant, Newborn
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin to skin contact immediateOther
Immediate SSC (intervention group) At birth, the baby will be dried and placed at the mother's breast where thermoregulation maneuvers will be applied and, once cord clamping has taken place, the baby will be left in SSC with the mother where the immediate neonatal adaptation interventions will take place. Mother and baby will be left in SSC for at least 1 h or until the baby has completed its first lactation properly. Once completed, the baby will be taken to the heat lamp to perform and complete all the newborn mediate adaptation interventions. If the mother expresses the desire to continue in SSC, this will be allowed again after these interventions. During immediate SSC, mother and baby will receive continuous monitoring by the health staff.
skin to skin contact earlyOther
Early SSC group (control group) At birth, the baby will be dried and placed on the abdomen and chest of their mother where thermoregulation maneuvers are applied once cord clamping has been completed. At this time, the baby will placed under the radiant heat lamp in order to complete all newborn adaptation interventions. Once stable, the mother and the baby will proceed with the initiation of SSC for at least 1 h or until the baby has completed the first lactation adequately; SSC will be allowed to continue if the mother expresses a desire to do so. During SSC, the mother and baby will receive monitoring by health personnel. All adaptation interventions, mediate and immediate, in the newborn will take place under the radiant heat lamp during the first postnatal hour.
| Study group | Role | What they receive |
|---|---|---|
| Skin to skin contact immediate | Experimental | At birth, the baby will be placed and dried on the breast of his mother where thermoregulation manoeuvres will be applied and once the cord clamping procedure has taken place; the baby will be left in SSC with the mother where the immediate neonatal adaptation interventions will take place. Mother and baby will be left in SSC for at least one hour or until the baby has completed its first lactation properly. Once completed, the baby will be taken to the heat lamp to perform and complete all the newborn mediate adaptation interventions. If the mother expresses the desire to continue in SSC, it will be allowed again after these interventions. During immediate SSC, mother and baby receive continuous monitoring by the health staff Receives: Other: Skin to skin contact immediate |
| skin to skin contact early | Active comparator | At birth, the baby will be dried and placed on the abdomen and chest of his mother where thermoregulation manoeuvres are applied once there is an indication that the cord clamp procedure has been completed. At this time the baby will go to the radiant heat lamp in order to complete all newborn adaptation interventions. Once stable, the mother and the baby who has 60 minutes of life, will proceed with the initiation of SSC for at least one hour or until the baby has completed the first lactation adequately; SSC will be allowed to continue if the mother expresses a desire to do so. During SSC the mother and baby will receive monitoring by health personnel Receives: Other: skin to skin contact early |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exclusive human lactation
Exclusive human lactation for 3 or more months. Exclusive human lactation is defined as: the time in months of human lactation as the only food source without having received other liquids or solid foods (except drugs and / or vitamins)
Measured: Through study completion, an average of 6 months
Secondary outcomes (4)
Human lactation capacity in the newborn
Human lactation capacity in the newborn within the first 24 hours of life by IBFAT Scale
Measured: within the first 24 hours of life
Maternal satisfaction with breastfeeding
Maternal satisfaction with breastfeeding in the first 24 hours according to the IBFAT Scale
Measured: First 24 hours
Evolution of birth weight
Evolution of birth weight in the first week of life.
Measured: First week of life
The need for hospitalization in the neonatal care unit
The need for hospitalization in the neonatal care unit in the first week of life.
Measured: First week of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startSep 2018 (estimated)
- Primary completionFeb 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast FeedingStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de la Sabana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Andrés Gamboa Garay, Universidad de la Sabana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687685
- Sponsor's protocol ID
- Acta 313 05-09-2015
- Acronym
- CPPITLH
- Status last verified
- Jul 2018
- First submitted
- 2 Feb 2016
- Last updated
- 17 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the committee required each month informations about adverse events and informs of recruitment each six months
Publications
Agudelo SI, Molina CF, Gamboa OA, Acuna E. Comparison of the Effects of Different Skin-to-Skin Contact Onset Times on Breastfeeding Behavior. Breastfeed Med. 2021 Dec;16(12):971-977. doi: 10.1089/bfm.2021.0134. Epub 2021 Sep 7.
PubMed 34494889Agudelo SI, Gamboa OA, Acuna E, Aguirre L, Bastidas S, Guijarro J, Jaller M, Valderrama M, Padron ML, Gualdron N, Obando E, Rodriguez F, Buitrago L. Randomized clinical trial of the effect of the onset time of skin-to-skin contact at birth, immediate compared to early, on the duration of breastfeeding in full term newborns. Int Breastfeed J. 2021 Apr 13;16(1):33. doi: 10.1186/s13006-021-00379-z.
PubMed 33849584Agudelo S, Gamboa O, Rodriguez F, Cala S, Gualdron N, Obando E, Padron ML. The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clinica Universidad de La Sabana: study protocol for a randomized clinical trial. Trials. 2016 Oct 26;17(1):521. doi: 10.1186/s13063-016-1587-7.
PubMed 27782829
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of Immediate Skin to Skin Contact (SSC) at Birth, Early vs. Immediate, on the Duration of Exclusive Human Lactation in Full-term Newborns Treated at the Universidad de La Sabana Clinic
- ClinicalTrials.gov ID
- NCT02687685
- Acronym / sponsor ID
- CPPITLH / Acta 313 05-09-2015
- Conditions
- Breast Feeding
- Keywords
- Skin to Skin Contact, Infant, Newborn
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Universidad de la SabanaUniversity, hospital or other
- Study start
- Sep 2018 (estimated)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 22 Feb 2016 (estimated)
- 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.
SUMMARY: Human lactation is a simple, cost-effective strategy contributing to infant and maternal mortality control. Skin to skin contact (SSC), is an immediate postpartum period strategy that has proven to benefit the initiation and continuation of human lactation and decreased hospitalization during the first week of life. This study aims to determine the effect of the initiation of SSC at birth (immediate vs. early) in healthy, full term newborns treated at Universidad de La Sabana Clinic, on the duration of exclusive human lactation.
Research question: What is the effect of immediate SSC at birth (immediate vs. early) on the duration of exclusive human lactation in full-term newborns treated at the Universidad de La Sabana Clinic?
Methodology: A random blind clinical trial was performed in which full-term healthy newborns that are attended at the Universidad de La Sabana Clinic are included. The blind participants will be those persons measuring the results and analysing the data. The sample size is calculated for a type I error of 5%, a two tailed type II error of 20%, therefore estimating percentage losses of 30%; 150 infants were included per group. Randomization will be performed using permuted, size 6 blocks. Descriptive analysis will be conducted using central tendency and dispersion measurements. A bivariate analysis will be performed to determine which variables are associated with exclusive human lactation at 6 months. For continuous variables, the Student t- test will be used for independent samples or the Wilcoxon rank sum test, in case the assumptions of normality for the t-tests are not fulfilled. The assumption of normality will be evaluated with the Shapiro Wilk and Kolmogorov-Smirnov test. Categorical variables in contingency tables will be constructed, assessing independence between variables with the Chi-square test or Fisher's exact test when the assumption of the number of cases is not met by the cells in the contingency tables, times two. It will be calculated as a measurement of the effect of relative risk (RR) with confidence intervals; the adjusted measurements will be calculated using a multivaried regression Poisson model, variables with significant results will be used in the bivariate analysis and those with biological plausibility used for the adjustment. The analysis will be carried out for a two-tailed type I error level of 5%. The Stata 11 program will be used for the data analysis. An interim analysis will be performed upon submission of half of the expected events (106), setting limits for early termination of the trial according to the method proposed by Pampallona and Tsiatis (1994).
Intervention: There will be 2 SSC randomization groups, early vs. immediate. After completing the neonatal adaptation process and according to the group assignment, it will proceed to leave the newborn with the mother in accommodation. Prior to discharge, the IBFAT scale will be applied. Monitoring will initially be performed with a face valuation between 3 and 10 days of life, then monthly telephone calls for 6 months to verify the status of human lactation.
Results: To determine whether early versus immediate SSC has an impact on the duration of exclusive human lactation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin to skin contact immediate | Experimental | Other: Skin to skin contact immediateAt birth, the baby will be placed and dried on the breast of his mother where thermoregulation manoeuvres will be applied and once the cord clamping procedure has taken place; the baby will be left in SSC with the mother where the immediate neonatal adaptation interventions will take place. Mother and baby will be left in SSC for at least one hour or until the baby has completed its first lactation properly. Once completed, the baby will be taken to the heat lamp to perform and complete all the newborn mediate adaptation interventions. If the mother expresses the desire to continue in SSC, it will be allowed again after these interventions. During immediate SSC, mother and baby receive continuous monitoring by the health staff |
| skin to skin contact early | Active comparator | Other: skin to skin contact earlyAt birth, the baby will be dried and placed on the abdomen and chest of his mother where thermoregulation manoeuvres are applied once there is an indication that the cord clamp procedure has been completed. At this time the baby will go to the radiant heat lamp in order to complete all newborn adaptation interventions. Once stable, the mother and the baby who has 60 minutes of life, will proceed with the initiation of SSC for at least one hour or until the baby has completed the first lactation adequately; SSC will be allowed to continue if the mother expresses a desire to do so. During SSC the mother and baby will receive monitoring by health personnel |
Who may qualify
- Ages
- Up to 60 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infants of mothers who express before the birth, their desire to breastfeed their newborn baby.
- Infants born between 7:00 am and 5:00 pm Monday through Friday in the USC.
- Full-term newborns defined by obstetric method and confirmed by paediatric method (Ballard), between 37 and 42 weeks of gestation, with appropriate weight for gestational age (between 10th and 90th percentiles for gestational age).
- Vaginal birth.
- Do not require basic or advanced neonatal resuscitation manoeuvres.
Key exclusion criteria (4 listed)
- Mothers and newborns that present absolute or relative contraindications for human lactation.
- Multiple births and pregnancies.
- Mothers with postpartum complications that limit the onset of human lactation.
- Major congenital malformations that prevent human lactation.
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 immediateImmediate SSC (intervention group) At birth, the baby will be dried and placed at the mother's breast where thermoregulation maneuvers will be applied and, once cord clamping has taken place, the baby will be left in SSC with the mother where the immediate neonatal adaptation interventions will take place. Mother and baby will be left in SSC for at least 1 h or until the baby has completed its first lactation properly. Once completed, the baby will be taken to the heat lamp to perform and complete all the newborn mediate adaptation interventions. If the mother expresses the desire to continue in SSC, this will be allowed again after these interventions. During immediate SSC, mother and baby will receive continuous monitoring by the health staff. | Other | Skin to skin contact immediate |
| skin to skin contact earlyEarly SSC group (control group) At birth, the baby will be dried and placed on the abdomen and chest of their mother where thermoregulation maneuvers are applied once cord clamping has been completed. At this time, the baby will placed under the radiant heat lamp in order to complete all newborn adaptation interventions. Once stable, the mother and the baby will proceed with the initiation of SSC for at least 1 h or until the baby has completed the first lactation adequately; SSC will be allowed to continue if the mother expresses a desire to do so. During SSC, the mother and baby will receive monitoring by health personnel. All adaptation interventions, mediate and immediate, in the newborn will take place under the radiant heat lamp during the first postnatal hour. | Other | skin to skin contact early |
Primary outcome
Exclusive human lactation
Time frame: Through study completion, an average of 6 months
Exclusive human lactation for 3 or more months. Exclusive human lactation is defined as: the time in months of human lactation as the only food source without having received other liquids or solid foods (except drugs and / or vitamins)
4 secondary outcomes
Human lactation capacity in the newborn
Time frame: within the first 24 hours of life
Maternal satisfaction with breastfeeding
Time frame: First 24 hours
Evolution of birth weight
Time frame: First week of life
The need for hospitalization in the neonatal care unit
Time frame: First week of life
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Derived from this study: PubMed 34494889Agudelo SI, Molina CF, Gamboa OA, Acuna E. Comparison of the Effects of Different Skin-to-Skin Contact Onset Times on Breastfeeding Behavior. Breastfeed Med. 2021 Dec;16(12):971-977. doi: 10.1089/bfm.2021.0134. Epub 2021 Sep 7.
- Derived from this study: PubMed 33849584Agudelo SI, Gamboa OA, Acuna E, Aguirre L, Bastidas S, Guijarro J, Jaller M, Valderrama M, Padron ML, Gualdron N, Obando E, Rodriguez F, Buitrago L. Randomized clinical trial of the effect of the onset time of skin-to-skin contact at birth, immediate compared to early, on the duration of breastfeeding in full term newborns. Int Breastfeed J. 2021 Apr 13;16(1):33. doi: 10.1186/s13006-021-00379-z.
- Derived from this study: PubMed 27782829Agudelo S, Gamboa O, Rodriguez F, Cala S, Gualdron N, Obando E, Padron ML. The effect of skin-to-skin contact at birth, early versus immediate, on the duration of exclusive human lactancy in full-term newborns treated at the Clinica Universidad de La Sabana: study protocol for a randomized clinical trial. Trials. 2016 Oct 26;17(1):521. doi: 10.1186/s13063-016-1587-7.
- Individual participant dataSharing planned: Yes. the committee required each month informations about adverse events and informs of recruitment each six months
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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.
1 site 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 immediate and skin to skin contact early in people with Breast Feeding, run by Universidad de la Sabana at 1 site in Colombia.
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 7 inclusion and 4 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 17 Jul 2018. 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 Colombia. 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?
Exclusive human lactation (time frame: Through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02687685, which also lists 3 linked publications.
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 17 Jul 2018.