PENGARUH PERAWATAN METODE KANGURU DINI TERHADAP PENYAPIHAN OKSIGEN DAN TINGKAT KECEMASAN IBU
| 1. Background | |
|---|---|
| Registration Number | INA-8TBZQ2Q9 |
| Date of registry approval | 10-06-2025 |
| Registration Date | 08-06-2025 |
| Secondary identifiers | Yes |
| Name of issuing authority (for example protocol number, other registries, etc) | INA-5ZP1TRG4 |
| Secondary identifier number | Not Specified |
| Scientific study title | PENGARUH PERAWATAN METODE KANGURU DINI TERHADAP PENYAPIHAN OKSIGEN DAN TINGKAT KECEMASAN IBU |
| Public (popular study title) | PENGARUH PERAWATAN METODE KANGURU DINI TERHADAP PENYAPIHAN OKSIGEN DAN TINGKAT KECEMASAN IBU |
| 2. Sponsor and Funding | |
| Primary Sponsor | None |
| Source(s) of monetary or material support | none |
| Other partners | Not Specified |
| 3. Contact details | |
| Principal Investigator | |
| Principal investigator | Endah Dessirya |
| City | Jakarta Timur |
| Country | Indonesia |
| Principal investigator's affiliation | Universitas Indonesia |
| Principal Investigator's email address | endahazzahra17@gmail.com |
| Public Queries | |
| Contact person name for public queries | Endah Dessirya |
| Address for public queries | Jl. Rawa Bola Kelapa Dua Wetan Ciracas Jakarta Timur |
| City | Jakarta Timur |
| Country | Indonesia |
| ZIP | 13730 |
| Affiliation for public queries | Universitas Indonesia |
| Email address for public queries | endahazzahra17@gmail.com |
| Phone number for public queries | 085780960641 |
| Scientific Queries | |
| Name of Contact for scientific queries | Prof. Yeni Rustina, S.Kp., M.App.Sc., Ph.D |
| Address for scientific queries | Prof. Dr. Bahder Djohan, Kampus UI Depok, Pondok Cina, Kecamatan Beji, Kota Depok, Jawa Barat 16424, Indonesia |
| City | Depok |
| Country | Indonesia |
| ZIP | 16424 |
| Affiliation of scientific queries contact | Universitas Indonesia |
| Email address for scientific queries | endahazzahra17@gmail.com |
| 4. IRB & Regulatory | |
| Ethical Approval number | PP.05.01/D.XXI.18/132/2025 |
| Name of Ethics committee | Komite Etik Penelitian Kesehatan RSUP Fatmawati Jakarta |
| Date of Ethic approval | 25-03-2025 |
| Contact details of Ethic Committee (phone, email, and office) | Address: Jalan RS. Fatmawati Raya Nomor 4 Jakarta Phone: (021)7501524 http://www.rs-fatmawati.go.id |
| Number of Persetujuan Pelaksanaan Uji Klinik (PPUK)/Persetujuan Protokol Uji BE (PPUB) | Not applicable |
| 5. Status | |
| Countries of recruitment | Jakarta |
| Study sites in Indonesia | RSUP Fatmawati, RSUPN Dr. Cipto Mangunkusumo |
| Recruitment status | Initial |
| Date of first enrollment | 01-04-2025 |
| Targeted Sample size | 00034 - |
| Number of enrolled participants | 34 |
| Date of study completion (last participant, last visit) | |
| 6. Study Design & Purpose | |
| Primary health condition(s) or problem(s) studied (e.g., depression, breast cancer,medication error) | low birth weight and anxiety scale mother |
| Purpose of the study | Treatment |
| Study type | Interventional |
| Interventional Study category | Interventional, other than clinical trial |
| Method of allocation | Randomized allocation |
| Description of the allocation concealment mechanism and sequence generation | The randomization process divided the participants two group intervention group and control group, using comput-generated randomization via https://www.randomlists.com. |
| Masking | Single blind (participants) |
| Study intervention (study arm) | The intervention group received early Kangaroo care start |
| Control intervention (control arm) | The control group received Kangaroo care start > 4 days Kangaroo care according to hospital standards |
| Intervention assignment | Parallel |
| 7. Eligibility Criteria | |
| Gender inclusion criteria | Not specified |
| Minimum age | Chronological age ≤ 4 days |
| Maximum age | >4 days |
| Inclusion criteria | 1. Low birth weight infants (1000-2000 gram)
2. Stable 3. use ventilation non invasive |
| Exclusion criteria | congenital anomaly |
| 8. Study Outcome | |
| Primary Outcome | |
| Name of primary outcome | Weaning oxygenation |
| Metric/method of measurement | chart observation oxygenation |
| Timepoint(s) of measurement | Fisrt day and 7th day |
| Secondary outcome 1 | |
| Name of secondary outcome 1 (SO1) | maternal anxiety |
| Metric/method of measurement (SO1) | STAI T kuesioner |
| Timepoint(s) of measurement (SO1) | fist day and 7th day |
| 9. Study Results | |
| Brief summary of study results | |
| Date of results summaries | |
| Participant flow | |
| Baseline characteristic | 1. Low birth weight infants (1000-2000 gram)
2. Stable 3. use ventilation non invasive |
| Adverse events | |
| Outcome measures | |
| 10. Publication | |
| URL hyperlink(s) related to results and publications | |
| IPD sharing statement (Statement regarding the intended sharing of deidentified individual clinical trial participant-level data (IPD)) | No |
| Plan for IPD sharing (what IPD will be shared, when, by what mechanism, with whom, and for what types of analyses) | |
| Other important informations | Not Sepcified |