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Newborn HypothermiaNCT05425394

A Study of Effects of Delay in the First Bathing Time of Body Temperature and the Rate of Exclusive Breastfeeding

A study testing Delay first bath in people with Newborn Hypothermia, run by Cardinal Tien Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery cases, and randomly assigned to the delayed bathing group and the routine bathing group , 10… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Newborn Hypothermia
What is being tested?
Delay first bath
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTaiwan
Study dates
2 Sep 2021to 25 Jan 2022
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

  • Apparently normal newborn with status ranging from normal to good
  • mean gestational age ≥37 weeks
  • birth weight ≥2500 g
  • Apgar score of at least 7 within 1-5 minutes
  • birth rectal temperature ≥36.5°C
  • without any major change or signs or symptoms of sepsis.

Who cannot join

  • The mother is younger than 20 years old
  • has recently had symptoms of fever, leukocytosis, respiratory tract infection or urinary tract infection
  • the mother has diseases such as diabetes, hyperthyroidism, and a positive history of type B streptococcus or other blood and body fluid infectious diseases.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • DiLing Huang

    New Taipei City, 235

Other trials in Taiwan

About this study

Official title: A Study of Effects of Delay in the First Bathing Time of Newborns on the Rate of Body Temperature and the Rate of Exclusive Breastfeeding: A Randomized Controlled Trial

Using delaying the first bathing by 8 hours as an interventional measure, considering the consistent effect of physiological maturity, newborns with a gestational age of ≥37 weeks were selected as the subjects in the nursery cases, and randomly assigned to the delayed bathing group and the routine bathing group , 10 minutes before bathing, immediately after bathing, 10 minutes, 30 minutes, and 60 minutes to analyze the differences in body temperature of the cases, and the differences in the rate of exclusive breastfeeding at discharge.

Read the detailed description

The subjects of this study came from newborn babies in the nursery of a teaching hospital in the northern region. The research design was reviewed and approved by the Human Trials Committee. Can freely choose whether to participate in the research project or withdraw, willing participants to inform the research project and fill in the consent form and basic information form, inform that they can withdraw at any time during the research period, and divide the participating infants into the experimental group and the control group through a random allocation form , after the newborn arrives in the baby room, the nursing staff will evaluate the newborn, and then perform an oil bath with baby oil to remove the fetal fat on the body, and then follow the newborn bathing procedure of our hospital. Wash the whole body with water, about 1-2 hours after birth; the control group took the first bath as usual; the experimental group postponed the last step of washing the whole body after washing the face and head to 8 hours after birth , personnel must wear gloves to take care of newborns before bathing. The bathing process was performed by nurses in the baby room. Body temperature was measured 10 minutes before, immediately after, 10 minutes, 30 minutes, and 60 minutes after bathing, and the exclusive breastfeeding situation at the time of discharge was counted. After all measurements are completed, a 100 yuan supermarket coupon will be given.

Being tested
Delay first bath
Keywords
delayed bathing, body temperature, breastfeeding
Medical subject headings
Breast Feeding

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Delay first bathBehavioural

    Newborns delay first bath to 8 hours after birth

Study groups in NCT05425394
Study groupRoleWhat they receive
delayed first bath timeExperimentalDelay first bath to 8 hours after birth
Receives: Behavioral: Delay first bath
regular bathNo interventionBirth temperature 36.5°C, regular bath

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. body temperature after bath

    The degree of decrease in body temperature after bathing compared to before bathing

    Measured: temperature measurement : 10 minutes after bathing

Secondary outcomes (1)

  1. Exclusive breastfeeding rate

    Neonatal feeding methods during hospitalization

    Measured: 3 to 5 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start2 Sep 2021
  3. Primary completion25 Jan 2022
  4. Study completion25 Jan 2022

Resources

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
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05425394
Sponsor's protocol ID
DHuang-0001
Status last verified
Jun 2022
First submitted
7 Jun 2022
Last updated
21 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: This study is a personal research project, and the subject's instructions and consent form for human trials inform the subjects that the data in the study is for this study only.

Publications

  • Wang Yating, Wang Xiuhe, Wu Sujin, Zheng Yufang, Liao Wenling (2014). A study on the choice of feeding method and its related factors in parturients. Joseph Medical Journal, 8(1), 5-16.

  • Lin Yujing, Yang Jialing, Gao Meihua, Li Jingyi (2012). Correlation between perinatal breastfeeding instruction and maternal practice of 24-hour parent-child rooming. Chang Gung Nursing, 23(1), 27-40.

  • Lin YW, Tzeng YL, Yang YL. [Mother-friendly childbirth practices and breastfeeding]. Hu Li Za Zhi. 2013 Feb;60(1):5-10. doi: 10.6224/JN.60.1.5. Chinese.

    PubMed 23386519

  • Ke Huijuan, Zhong Yulun, Chen Shufen (2019). A retrospective cohort study on the effect of continuous exclusive breastfeeding on the 24-hour parent-child rooming strategy in a medical center. Rong Total Nursing, 36(4), 343-352.

  • Xu Yufen, Liu Xinyi, Li Zhaohui, Chen Shujuan (2010). Improvement programs to reduce the incidence of neonatal hypothermia. Journal of Midwifery, 52, 93-104.

  • Gao Yuxiu, Li Fengxue, and Wang Guoming (2012). Influence of primipara background factors on breastfeeding experience and self-efficacy. Journal of Midwifery, 54, 56-67.

  • Chen Guanying, Wei Ziyi, Huang Xiaoyu, Xu Yunxin (2019). A project to improve hypothermia for neonates admitted to the moderate-severe ward in the delivery room. Journal of Nursing, 66(4), 71-78.

  • You Shuzhen (2018). Discussion on the related factors of continuous breastfeeding in postpartum women.

  • Ye Jinxue (2015). The Guardianship of Successful Breastfeeding. Taiwan Medicine, 19(6), 643-649.

  • Anderson J. An Organization-Wide Initiative to Implement Parent-Performed, Delayed Immersion Bathing. Nurs Womens Health. 2021 Feb;25(1):63-70. doi: 10.1016/j.nwh.2020.11.006. Epub 2021 Jan 13.

    PubMed 33450241

  • Association of Women's Health, Obstetric and Neonatal Nurses. （2018）. Neonatal skin care: Evidence-based clinical practice guideline （4th ed.）. AWHONN.

  • Bhutta ZA, Das JK, Bahl R, Lawn JE, Salam RA, Paul VK, Sankar MJ, Blencowe H, Rizvi A, Chou VB, Walker N; Lancet Newborn Interventions Review Group; Lancet Every Newborn Study Group. Can available interventions end preventable deaths in mothers, newborn babies, and stillbirths, and at what cost? Lancet. 2014 Jul 26;384(9940):347-70. doi: 10.1016/S0140-6736(14)60792-3. Epub 2014 May 19.

    PubMed 24853604

  • Binns C, Lee MK, Kagawa M. Ethical Challenges in Infant Feeding Research. Nutrients. 2017 Jan 11;9(1):59. doi: 10.3390/nu9010059.

    PubMed 28085057

  • Bissinger RL, Annibale DJ. Thermoregulation in very low-birth-weight infants during the golden hour: results and implications. Adv Neonatal Care. 2010 Oct;10(5):230-8. doi: 10.1097/ANC.0b013e3181f0ae63.

    PubMed 20838071

  • Blackburn, S. T., （2003）. Thermoregulation. In S. T. Blackburn （Ed.）, Maternal, fetal, & neonatal physiology: A clinical perspective （2nd ed., pp. 707-730）. Philadelphia, Saunders.

Questions about this trial

What is this clinical trial studying?

A study testing Delay first bath in people with Newborn Hypothermia, run by Cardinal Tien Hospital at 1 site 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 6 inclusion and 3 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 21 Jun 2022. 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 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?

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?

body temperature after bath (time frame: temperature measurement : 10 minutes after bathing). 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 NCT05425394, which also lists 79 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 21 Jun 2022.

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