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NCT Number: NCT07599332

Observational Study Exploring the Timing of Postnatal Neonate Weight Measurements

This study will help us address the national question of when is the best day to weigh neonates to ensure we give neonates the best possible chance within the first week of their life, maximizing breastmilk without giving formula unnecessarily for weight loss management, and improved maternal mental health.

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Observational

Primary location

East Suffolk and North Essex NHS Foundation Trust

Ipswich, United Kingdom

Location status: Recruiting

About this study

The impact of even 1 formula supplementation can have detrimental effects on both mum and baby; decreased eagerness to breastfeed - leading to low milk supply, can trigger allergic sensitisation, and loss of confidence for the mother in breastfeeding. Maternal mental health within the first week of the postnatal period can be a turbulent time with increased hormones levels and adapting to a new normal. Ensuring good well-being of mothers is incredibly important to ensure the mother is able to bond well with her baby - a healthy loving relationship between parents and babies is integral to the brain development of the baby. Exposure in the first 1 year of the baby's life is the most integral part in helping to shape their emotional, cognitive and social capabilities (HM Government, 2021). This research project is of local and national importance for patient and parent care to improve long term health benefits of protecting breastfeeding journeys.

The main aim of the study is to collect data on the weight of neonates in the first 5 days of life.

Women will be consented in the first 24 hours following the birth of their baby if they fit the criteria. Baseline information will be collected:

  • Time & Date of birth
  • Type of birth
  • Weight at birth
  • Any medical risk factors i.e diabetes, high blood pressure etc
  • Feeding type (breastfeeding, formula, or both)
  • Gestation at birth

A maternity support worker will be tasked with weighing all the babies as near to their birth times possible and all data will be collected and logged. Following this the data will be sorted and correlated to look for any trends:

  • What day had the biggest weight loss
  • When did the weight begin to increase
  • Were bigger weight losses linked with a certain type of birth or medical condition that the patient had
  • Did the gestational age when the baby was born have any link with greater weight loss

The end of the study will be defined as the date when the last baby entered into the study had had their final weight completed at the end of the 5-day period. This also included the collection of all weight data for the 5-day duration and any necessary data validation and quality checks. Following the final weight measurement, the data will be prepared for analysis to examine the trends in weight loss/gain over the study period. The results will be analysed and disseminated as outlined. Following on from this pilot study, it is hoped that a larger national study will take place to continue to collect weight loss data and help define the normal weight loss/gain which neonates experience in the first few days of life.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Any patient who births their baby within the timeframe of the data collection will be eligible to join the study

Exclusion criteria

  • Patients who birth their babies outside of the range as above.
  • Babies who are admitted to the neonatal unit from birth.
  • Mothers less than 16 years old

Treatment and study plan

Primary outcomes

  1. To find out when the best day to weigh a newborn baby is between birth and 5 days.

    Time frame: Between birth and 5 days old of newborn baby.

    This pilot sample with give us a baseline of data and help to calculate the data size needed to adequately power a larger multi-centre study to provide evidence to inform the best day/days to weight babies after birth and allow for the development phase of the production of individual weight loss charts for neonates. Babies will be weighed from day of birth up until 5 days old (5 separate weights)

Study contacts

Contact information is provided by the study sponsor or research team.

Hannah Stansfield

CONTACT

R&[email protected]

Stephanie Roberson

CONTACT

[email protected]

01473 703052

Sponsors and collaborators

Lead sponsor

East Suffolk and North Essex NHS Foundation Trust

Other

Registry information

Acronym: WEIGHT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.