Premature InfantNCT03070158
Affective Bonding in Mothers and Their Premature Newborn
A study testing Attachment Promotion in people with Premature Infant, run by Universidad Industrial de Santander at 3 sites in Colombia.
Trial summary
This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. Read more about this study
- Who is it for?
- Ages 29 to 36 weeks
- Conditions the study is for
- Premature Infant
- What is being tested?
- Attachment Promotion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 3 sitesColombia
- Study dates
- 1 May 2017to 30 Dec 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 29 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Premature Infant:
- Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.
- Apgar to the minute and five minutes greater to 7/10
- Mother:
- Mother with nursing diagnosis: Risk of impaired attachment.
- Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth
- Mother living in the metropolitan perimeter of the city of Bucaramanga
Who cannot join
- Newborn:
- Infants that underwent surgery
- Infants with neurological injury.
- Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.
- Mother:
- Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.
- Mother consuming psychoactive substances.
- With mental alterations, verified in the medical history.
Trial locations and contacts
3 sites in 1 country.
Colombia3 sites, 3 recruiting
- Recruiting
Nursing School, Universidad Industrial de Santander
Bucaramanga, Santander Department, 680002
Beatriz Villamizar- Carvajal, PhD, 576345745, beatriz@uis.edu.co
Beatriz Villamizar- Carvajal, RN PhD
- Recruiting
Clinica Materno Infantil San Luis
Bucaramanga, Santander Department, 680003
CRISTIAN ORDOÑEZ, Dr., 5776430026 ext. 495, asistente.medica@clinicasanluis.com.co
- Recruiting
Hospital Universitario de Santander
Bucaramanga, Santander Department, 680003
Helda Amaya, RN.Director, 577 6450102, heldow2003@yahoo.com
About this study
Official title: Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond
This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.
Read the detailed description
The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.
- Conditions
- Premature Infant
- Being tested
- Attachment Promotion
- Keywords
- Premature Infant, Mother-Infant Interaction, Acoustic stimulation/methods, Touch, Visual Stimulation, Vestibule, Labyrinth/physiology
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment PromotionBehavioural
Attachment Promotion consists of:
- Education session about newborn and mother care.
- Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular)
- Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention.
- Daily Phone follows up.
| Study group | Role | What they receive |
|---|---|---|
| Attachment Promotion Intervention | Experimental | Mothers will receive the intervention which includes an education session about newborn care, training in multisensory stimulation with the intervention ATVV and two domiciliary visits to follow up the mother and her premature infant. Receives: Behavioral: Attachment Promotion |
| Usual Care | No intervention | Mothers will continue to receive usual which consist in education session about newborn care in home. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective bonding score
Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)
Measured: 1-6 weeks
Secondary outcomes (1)
Coping adaptation score
Changes in the mean score of the coping measure with the Coping adaptation Processing Scale Abbreviated (CAPS Abbreviated - Spanish)
Measured: 1-6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 May 2017
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Villamizar Carvajal, Universidad Industrial de Santander
- Investigators
- Beatriz Villamizar- Carvajal, PhD, Principal investigator, Universidad Industrial de SantanderCarolina Vargas- Porras, Msc, Study chair, Universidad Industrial de SantanderMayut Delgado-Galeano, Msc, Study chair, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070158
- Sponsor's protocol ID
- 1900
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2017
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.
PubMed 22161578Kelly MM. Comparison of functional status of 8- to 12-year-old children born prematurely: an integrative review of literature. J Pediatr Nurs. 2012 Aug;27(4):299-309. doi: 10.1016/j.pedn.2011.03.010. Epub 2011 May 11.
PubMed 22703676Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.
PubMed 21045616Howland LC, Pickler RH, McCain NL, Glaser D, Lewis M. Exploring biobehavioral outcomes in mothers of preterm infants. MCN Am J Matern Child Nurs. 2011 Mar-Apr;36(2):91-7. doi: 10.1097/NMC.0b013e318205587e.
PubMed 21350371Forcada-Guex M, Borghini A, Pierrehumbert B, Ansermet F, Muller-Nix C. Prematurity, maternal posttraumatic stress and consequences on the mother-infant relationship. Early Hum Dev. 2011 Jan;87(1):21-6. doi: 10.1016/j.earlhumdev.2010.09.006. Epub 2010 Oct 15.
PubMed 20951514
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Nursing Intervention in the Mother-premature Infant Affective Bond
- ClinicalTrials.gov ID
- NCT03070158
- Acronym / sponsor ID
- 1900
- Conditions
- Premature Infant
- Keywords
- Premature Infant, Mother-Infant Interaction, Acoustic stimulation/methods, Touch, Visual Stimulation, Vestibule, Labyrinth/physiology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 3 Mar 2017 (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.
This experimental study will determine the effectiveness of nursing intervention "the attachment promotion" to increase the affective bonds between mothers and their premature infants. The assignment of the mothers to the control group will receive usual care, the mothers will be assigned to intervention group will receive the intervention.
Detailed description
The premature newborn has a high need for positive interactions, which is a challenge for him, due to biological immaturity, and for his mother because of the level of stress that this situation generates. Behavioral and developmental interventions are needed to address the unique behaviors of preterm infants and the interactive capacities of the mother-newborn premature dyad. The project will be conducted in 18 months. The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The assignment of the mothers to each group will be like that: First at all, mother will be assignment to control group. They will received usual care when achieve the total of 74 mothers, the mothers will be assigned to intervention group.
| Arm | Type | Receives |
|---|---|---|
| Attachment Promotion Intervention | Experimental | Behavioral: Attachment PromotionMothers will receive the intervention which includes an education session about newborn care, training in multisensory stimulation with the intervention ATVV and two domiciliary visits to follow up the mother and her premature infant. |
| Usual Care | No intervention | –Mothers will continue to receive usual which consist in education session about newborn care in home. |
Who may qualify
- Ages
- 29 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Neonates who had been hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks gestation at birth.
- Apgar to the minute and five minutes greater to 7/10
- Mother with nursing diagnosis: Risk of impaired attachment.
- Mother with a neonate who had hospitalized in the neonatal care unit, with ages ranging from 29 - 36.6/7 weeks of gestation at birth
- Mother living in the metropolitan perimeter of the city of Bucaramanga
Key exclusion criteria (8 listed)
- Infants that underwent surgery
- Infants with neurological injury.
- Congenital cardiac abnormalities, severe deformities, grade III intraventricular hemorrhage.
- Mother with limitations: hearing, motor and / or mental handicap-measured through the Abbreviated Mental Test (minimental), that prevent the intervention.
- Mother consuming psychoactive substances.
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 |
|---|---|---|
| Attachment PromotionAttachment Promotion consists of: 1. Education session about newborn and mother care. 2. Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular) 3. Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention. 4. Daily Phone follows up. | Behavioural | Attachment Promotion Intervention |
Primary outcome
Affective bonding score
Time frame: 1-6 weeks
Changes in the mean score of the nursing outcome: affective bonding measure with the NOC(Nursing Outcomes Classification)
1 secondary outcome
Coping adaptation score
Time frame: 1-6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Background: PubMed 22161578Femitha P, Bhat BV. Early neonatal outcome in late preterms. Indian J Pediatr. 2012 Aug;79(8):1019-24. doi: 10.1007/s12098-011-0620-9. Epub 2011 Dec 10.
- Background: PubMed 22703676Kelly MM. Comparison of functional status of 8- to 12-year-old children born prematurely: an integrative review of literature. J Pediatr Nurs. 2012 Aug;27(4):299-309. doi: 10.1016/j.pedn.2011.03.010. Epub 2011 May 11.
- Background: PubMed 21045616Pickler RH, McGrath JM, Reyna BA, McCain N, Lewis M, Cone S, Wetzel P, Best A. A model of neurodevelopmental risk and protection for preterm infants. J Perinat Neonatal Nurs. 2010 Oct-Dec;24(4):356-65. doi: 10.1097/JPN.0b013e3181fb1e70.
- Background: PubMed 21350371Howland LC, Pickler RH, McCain NL, Glaser D, Lewis M. Exploring biobehavioral outcomes in mothers of preterm infants. MCN Am J Matern Child Nurs. 2011 Mar-Apr;36(2):91-7. doi: 10.1097/NMC.0b013e318205587e.
- Background: PubMed 20951514Forcada-Guex M, Borghini A, Pierrehumbert B, Ansermet F, Muller-Nix C. Prematurity, maternal posttraumatic stress and consequences on the mother-infant relationship. Early Hum Dev. 2011 Jan;87(1):21-6. doi: 10.1016/j.earlhumdev.2010.09.006. Epub 2010 Oct 15.
- 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.
Beatriz Villamizar- Carvajal, PhD principal investigator
Universidad Industrial de Santander
Carolina Vargas- Porras, Msc study chair
Universidad Industrial de Santander
Mayut Delgado-Galeano, Msc study chair
Universidad Industrial de Santander
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Attachment Promotion in people with Premature Infant, run by Universidad Industrial de Santander at 3 sites 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 8 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 7 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Beatriz Villamizar- carvajal, PhD (5776345745, beatriz@uis.edu.co), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affective bonding score (time frame: 1-6 weeks). 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 NCT03070158, which also lists 5 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 7 Feb 2020.