Document is current

Article History

Received: 29 April 2025

Accepted: 9 September 2025

First Online: 29 September 2025

Declarations

:

: This study was approved by the Ethics Committee of Suqian Hospital Affiliated to Nanjing Medical University (approval number: 2024-SL-0212; date of approval: December 18, 2024) and the ethics committees of participating NICUs. Parents/guardians of the participants will be approached to explain the study aims, risk and benefits and at the time of recruitment. They will be encourages to provide written informed consent forms (There is still controversy regarding the impact of probiotic supplementation on NEC and mortality rates. Given this unresolved controversy, probiotic supplements will not be administered to participants throughout the entire trial.). Saline solution is widely used and well - tolerated medically. We systematically reviewed much literature on oropharyngeal colostrum administration. Given routine oral care in domestic NICUs, we chose saline as the control group. Ethically, based on equipoise and a thorough literature review, we believe it is reasonable to expose participants to the potential risks of the intervention, as we are likely to gain new knowledge that will benefit future patients. In addition, we will ensure them of the confidentiality of study and that the participant’s details will not be shared with anyone under any circumstances.

: Not applicable.

: The authors declare no competing interests.