Infant, Premature, DiseasesNCT04807088
Effect of Tactile-Kinesthetic Stimulation on Preterm Neonates
A study testing Tactile-kinesthetic Stimulation in people with Infant, Premature, Diseases, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital. Read more about this study
- Who is it for?
- Ages 6 to 24 hoursHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Diseases
- What is being tested?
- Tactile-kinesthetic Stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Aug 2015to 14 Jul 2017
- 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 6 to 24 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-24-hour-old preterm infants with 32-<37 gestational weeks
- birth weight ranging from 1,500 to <2,500 g
- appropriate for gestational age
- a minimum Apgar score of seven at the fifth minute
- no history of neonatal resuscitation
- stable vital condition
- no invasive therapy during hospitalisation
Who cannot join
- intrauterine growth retardation
- untreated clinical sepsis
- congenital abnormalities such as congenital heart disease
- history of hyperbilirubinemia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Tactile-Kinesthetic Stimulation on Growth, Neurobehavior and Development Among Preterm Neonates
An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.
Read the detailed description
Preterm neonates were recruited via random sampling and divided into two groups (intervention group and control group). A written informed consent was obtained from the parents or guardians.
Before the intervention, physical examination was performed to ensure the neonates had normal vital signs, were healthy and did not present with congenital abnormalities.
In the intervention group, TKS was performed with specific baby oil for 15 minutes, three times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or caregiver. TKS implementation at home was supervised by the investigator or nurse through phone call. The TKS were documented by the mother or caregiver in the diary card, which should be brought during the next visit when the neonate was 11-14 days old. In addition to TKS, history of illness and nutrition which was confirmed through history taking during hospital or home visit, was also recorded. The participants who did not go the hospital were home visited by the investigator or nurse.
Anthropometric measurement by investigator and trained nurses and Dubowitz examination was performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit, outpatient clinic or participants' home while the neonate was fully alert.
At 3 months of age, infant development was assessed by the investigator using the Capute scales (Developmental Quotient of Clinical Adaptive Test [DQ CAT], Clinical Linguistic Adaptive Milestone Scale [DQ CLAMS]) and the Full Scale Developmental Quotient (FS DQ) score. The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the child's performance according to the listed items.
- Conditions
- Infant, Premature, Diseases
- Being tested
- Tactile-kinesthetic Stimulation, Placebo
- Keywords
- preterm, growth, development, premature birth, infant, massage, weight gain
- Medical subject headings
- Infant, Premature, Diseases, Premature Birth, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tactile-kinesthetic StimulationProcedure or surgery
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Tactile-kinesthetic stimulation (TKS) was performed with a specific baby oil provided by the investigator. Tactile stimulation was performed while the neonate was in prone position. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Every massage was performed for 2 × 5 seconds, with a total duration of 5 minutes. Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 2 × 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 10 consecutive days. Receives: Procedure: Tactile-kinesthetic Stimulation |
| Control Group | Placebo comparator | Control group was not given TKS. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Birth Body Weight at 11 Days Old
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Measured: On the first day and 11 days old.
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Measured: On the first day and 40 weeks of postmenstrual age.
Change from Birth Body Weight at 3 Months Old
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Measured: On the first day and 3 months old.
Change from Birth Body Length at 11 Days Old
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Measured: On the first day and 11 days old.
Change from Birth Body Length at 40 Weeks of Postmenstrual Age
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Measured: On the first day and 40 weeks of postmenstrual age.
Change from Birth Body Length at 3 Months Old
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Measured: On the first day and 3 months old.
Change from Birth Head Circumference at 11 Days Old
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Measured: On the first day and 11 days old.
Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Measured: On the first day and 40 weeks of postmenstrual age.
Change from Birth Head Circumference at 3 Months Old
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Measured: On the first day and 3 months old.
Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Measured: 6-24 hours of age and 11-14 days of age.
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Measured: 6-24 hours of age and term or 40 weeks of postmenstrual age.
Change from 6-24 hours of age Neurobehavior at 3 Months Old
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Measured: 6-24 hours of age and 3 Months Old.
Infant Development
Using Capute scales.
Measured: 3 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2021
- Study start1 Aug 2015
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Infant, Premature, DiseasesStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Hartono Gunardi, MD, PhD, Universitas Indonesia
- Investigators
- Hartono Gunardi, MD, PhD, Principal investigator, Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04807088
- Sponsor's protocol ID
- 681/UN2.F1/ETIK/2015
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aliabadi F, Askary RK. Effects of tactile-kinesthetic stimulation on low birth weight neonates. Iran J Pediatr. 2013 Jun;23(3):289-94.
PubMed 23795251Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 Feb 14.
PubMed 28235686Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
PubMed 24625129Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27.
PubMed 24480603Dosman CF, Andrews D, Goulden KJ. Evidence-based milestone ages as a framework for developmental surveillance. Paediatr Child Health. 2012 Dec;17(10):561-8. doi: 10.1093/pch/17.10.561.
PubMed 24294064Dubowitz L, Ricciw D, Mercuri E. The Dubowitz neurological examination of the full-term newborn. Ment Retard Dev Disabil Res Rev. 2005;11(1):52-60. doi: 10.1002/mrdd.20048.
PubMed 15856443Elmoneim MA, Mohamed HA, Awad A, El-Hawary A, Salem N, El Helaly R, Nasef N, Abdel-Hady H. Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants. Eur J Pediatr. 2021 Jan;180(1):207-215. doi: 10.1007/s00431-020-03738-w. Epub 2020 Jul 14.
PubMed 32666281Akhavan Karbasi S, Golestan M, Fallah R, Golshan M, Dehghan Z. Effect of body massage on increase of low birth weight neonates growth parameters: A randomized clinical trial. Iran J Reprod Med. 2013 Jul;11(7):583-8.
PubMed 24639794Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6.
PubMed 21048258Mathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactile-kinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001 Oct;38(10):1091-8.
PubMed 11677298Moddemann D, Shea S. The developmental paediatrician and neonatal follow-up. Paediatr Child Health. 2006 May;11(5):295.
PubMed 19030294Orton J, Spittle A, Doyle L, Anderson P, Boyd R. Do early intervention programmes improve cognitive and motor outcomes for preterm infants after discharge? A systematic review. Dev Med Child Neurol. 2009 Nov;51(11):851-9. doi: 10.1111/j.1469-8749.2009.03414.x. Epub 2009 Sep 1.
PubMed 19732117Sankaranarayanan K, Mondkar JA, Chauhan MM, Mascarenhas BM, Mainkar AR, Salvi RY. Oil massage in neonates: an open randomized controlled study of coconut versus mineral oil. Indian Pediatr. 2005 Sep;42(9):877-84.
PubMed 16208048Santos IS, Matijasevich A, Domingues MR, Barros AJ, Victora CG, Barros FC. Late preterm birth is a risk factor for growth faltering in early childhood: a cohort study. BMC Pediatr. 2009 Nov 16;9:71. doi: 10.1186/1471-2431-9-71.
PubMed 19917121Soriano CR, Martinez FE, Jorge SM. Cutaneous application of vegetable oil as a coadjutant in the nutritional management of preterm infants. J Pediatr Gastroenterol Nutr. 2000 Oct;31(4):387-90. doi: 10.1097/00005176-200010000-00011.
PubMed 11045835
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tactile-Kinesthetic Stimulation on Growth, Neurobehavior and Development Among Preterm Neonates
- ClinicalTrials.gov ID
- NCT04807088
- Acronym / sponsor ID
- 681/UN2.F1/ETIK/2015
- Conditions
- Infant, Premature, Diseases
- Keywords
- preterm, growth, development, premature birth, infant, massage, weight gain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 19 Mar 2021 (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.
An interventional study to evaluate the effect of tactile-kinesthetic stimulation (TKS) on growth, neurobehavior and development among preterm neonates in the neonatal unit of Dr. Cipto Mangunkusumo Hospital.
Detailed description
Preterm neonates were recruited via random sampling and divided into two groups (intervention group and control group). A written informed consent was obtained from the parents or guardians.
Before the intervention, physical examination was performed to ensure the neonates had normal vital signs, were healthy and did not present with congenital abnormalities.
In the intervention group, TKS was performed with specific baby oil for 15 minutes, three times a day, for 10 days. After 10 days, TKS was applied once daily by the mother or caregiver. TKS implementation at home was supervised by the investigator or nurse through phone call. The TKS were documented by the mother or caregiver in the diary card, which should be brought during the next visit when the neonate was 11-14 days old. In addition to TKS, history of illness and nutrition which was confirmed through history taking during hospital or home visit, was also recorded. The participants who did not go the hospital were home visited by the investigator or nurse.
Anthropometric measurement by investigator and trained nurses and Dubowitz examination was performed by investigator in a warm and quiet place in the neonatal unit, mother-baby unit, outpatient clinic or participants' home while the neonate was fully alert.
At 3 months of age, infant development was assessed by the investigator using the Capute scales (Developmental Quotient of Clinical Adaptive Test [DQ CAT], Clinical Linguistic Adaptive Milestone Scale [DQ CLAMS]) and the Full Scale Developmental Quotient (FS DQ) score. The Clinical Linguistic Adaptive Milestone Scale (CLAMS) score was based on the parent's report of language skill attainment. The Clinical Adaptive Test (CAT) score was based on the child's performance according to the listed items.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Procedure: Tactile-kinesthetic StimulationTactile-kinesthetic stimulation (TKS) was performed with a specific baby oil provided by the investigator. Tactile stimulation was performed while the neonate was in prone position. Light massage was applied in the head, shoulder, back, legs and arms of the infants. Every massage was performed for 2 × 5 seconds, with a total duration of 5 minutes. Kinesthetic stimulation, including elbow flexion-extension movement, palm massages, flexion-extension of the knees and legs and plantar massages, was applied while the neonate was in supine position. Each kinesthetic stimulation was performed for 2 × 5 seconds. Each movement was repeated six times, with a total duration of 5 minutes. Tactile stimulation was repeated once after kinesthetic stimulation. The total duration of TKS was 15 minutes which was performed three times daily preferably between breastfeeding or bottle feeding for 10 consecutive days. |
| Control Group | Placebo comparator | Other: PlaceboControl group was not given TKS. |
Who may qualify
- Ages
- 6 to 24 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 6-24-hour-old preterm infants with 32-<37 gestational weeks
- birth weight ranging from 1,500 to <2,500 g
- appropriate for gestational age
- a minimum Apgar score of seven at the fifth minute
- no history of neonatal resuscitation
Key exclusion criteria (4 listed)
- intrauterine growth retardation
- untreated clinical sepsis
- congenital abnormalities such as congenital heart disease
- history of hyperbilirubinemia
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 |
|---|---|---|
| Tactile-kinesthetic Stimulation | Procedure or surgery | Intervention Group |
| Placebo | Other | Control Group |
Primary outcome
Change from Birth Body Weight at 11 Days Old
Time frame: On the first day and 11 days old.
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Change from Birth Body Weight at 40 Weeks of Postmenstrual Age
Time frame: On the first day and 40 weeks of postmenstrual age.
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Change from Birth Body Weight at 3 Months Old
Time frame: On the first day and 3 months old.
Scale in grams. Using calibrated baby scale with accuracy of 10g, plotted in 2013 Fenton growth chart. The measurement was obtained twice if the same result was obtained and three times if the results differed. The mean was calculated.
Change from Birth Body Length at 11 Days Old
Time frame: On the first day and 11 days old.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from Birth Body Length at 40 Weeks of Postmenstrual Age
Time frame: On the first day and 40 weeks of postmenstrual age.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from Birth Body Length at 3 Months Old
Time frame: On the first day and 3 months old.
Scale in centimeters. Using a length board, plotted in 2013 Fenton growth chart.
Change from Birth Head Circumference at 11 Days Old
Time frame: On the first day and 11 days old.
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Change from Birth Head Circumference at 40 Weeks of Postmenstrual Age
Time frame: On the first day and 40 weeks of postmenstrual age.
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Change from Birth Head Circumference at 3 Months Old
Time frame: On the first day and 3 months old.
Scale in centimeters. Using a non-elastic tape, plotted in 2013 Fenton growth chart. Head circumference was measured three times from the glabella to the posterior occiput, and the largest measurement was recorded.
Change from 6-24 hours of Age Neurobehavior at 11-14 Days of Age
Time frame: 6-24 hours of age and 11-14 days of age.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Change from 6-24 hours of age Neurobehavior at Term or 40 Weeks of Postmenstrual Age
Time frame: 6-24 hours of age and term or 40 weeks of postmenstrual age.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Change from 6-24 hours of age Neurobehavior at 3 Months Old
Time frame: 6-24 hours of age and 3 Months Old.
Using Dubowitz examination. The minimum Dubowitz score is 0 and the maximum is 72.
Infant Development
Time frame: 3 months of age.
Using Capute scales.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2021.
- Background: PubMed 23795251Aliabadi F, Askary RK. Effects of tactile-kinesthetic stimulation on low birth weight neonates. Iran J Pediatr. 2013 Jun;23(3):289-94.
- Background: PubMed 28235686Alvarez MJ, Fernandez D, Gomez-Salgado J, Rodriguez-Gonzalez D, Roson M, Lapena S. The effects of massage therapy in hospitalized preterm neonates: A systematic review. Int J Nurs Stud. 2017 Apr;69:119-136. doi: 10.1016/j.ijnurstu.2017.02.009. Epub 2017 Feb 14.
- Background: PubMed 24625129Blencowe H, Cousens S, Chou D, Oestergaard M, Say L, Moller AB, Kinney M, Lawn J; Born Too Soon Preterm Birth Action Group. Born too soon: the global epidemiology of 15 million preterm births. Reprod Health. 2013;10 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-10-S1-S2. Epub 2013 Nov 15.
- Background: PubMed 24480603Diego MA, Field T, Hernandez-Reif M. Preterm infant weight gain is increased by massage therapy and exercise via different underlying mechanisms. Early Hum Dev. 2014 Mar;90(3):137-40. doi: 10.1016/j.earlhumdev.2014.01.009. Epub 2014 Jan 27.
- Background: PubMed 24294064Dosman CF, Andrews D, Goulden KJ. Evidence-based milestone ages as a framework for developmental surveillance. Paediatr Child Health. 2012 Dec;17(10):561-8. doi: 10.1093/pch/17.10.561.
- Background: PubMed 15856443Dubowitz L, Ricciw D, Mercuri E. The Dubowitz neurological examination of the full-term newborn. Ment Retard Dev Disabil Res Rev. 2005;11(1):52-60. doi: 10.1002/mrdd.20048.
- Background: PubMed 32666281Elmoneim MA, Mohamed HA, Awad A, El-Hawary A, Salem N, El Helaly R, Nasef N, Abdel-Hady H. Effect of tactile/kinesthetic massage therapy on growth and body composition of preterm infants. Eur J Pediatr. 2021 Jan;180(1):207-215. doi: 10.1007/s00431-020-03738-w. Epub 2020 Jul 14.
- Background: PubMed 24639794Akhavan Karbasi S, Golestan M, Fallah R, Golshan M, Dehghan Z. Effect of body massage on increase of low birth weight neonates growth parameters: A randomized clinical trial. Iran J Reprod Med. 2013 Jul;11(7):583-8.
- Background: PubMed 21048258Kulkarni A, Kaushik JS, Gupta P, Sharma H, Agrawal RK. Massage and touch therapy in neonates: the current evidence. Indian Pediatr. 2010 Sep;47(9):771-6.
- Background: PubMed 11677298Mathai S, Fernandez A, Mondkar J, Kanbur W. Effects of tactile-kinesthetic stimulation in preterms: a controlled trial. Indian Pediatr. 2001 Oct;38(10):1091-8.
- Background: PubMed 19030294Moddemann D, Shea S. The developmental paediatrician and neonatal follow-up. Paediatr Child Health. 2006 May;11(5):295.
- Background: PubMed 19732117Orton J, Spittle A, Doyle L, Anderson P, Boyd R. Do early intervention programmes improve cognitive and motor outcomes for preterm infants after discharge? A systematic review. Dev Med Child Neurol. 2009 Nov;51(11):851-9. doi: 10.1111/j.1469-8749.2009.03414.x. Epub 2009 Sep 1.
- 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.
Hartono Gunardi, MD, PhD principal investigator
Pediatric Consultant, Head of Growth and Development-Social Pediatrics Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tactile-kinesthetic Stimulation in people with Infant, Premature, Diseases, run by Universitas Indonesia at 1 site in Indonesia.
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: finished, as of the sponsor's last update on 19 Mar 2021. 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 Indonesia. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Birth Body Weight at 11 Days Old (time frame: On the first day and 11 days old.). The study lists 13 primary outcomes in all. 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 NCT04807088, which also lists 17 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 19 Mar 2021.